An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00488631
Collaborator
Merck Sharp & Dohme LLC (Industry)
1,228
309
6
89
4
0
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This was a Phase 3, multicenter (conducted in more than one center), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), double-blind (neither the Physician nor the participant know about the study medication), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions), randomized-withdrawal study. Participants who were in clinical response to golimumab at Week 6 in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will be randomly assigned in a 1:1:1 ratio at Week 0 of this study to receive 1 of the following maintenance treatment regimens administered subcutaneously every 4 weeks through Week 52: placebo, golimumab 50 mg, or golimumab 100 mg. Participants who were in clinical response to placebo and participants who were not in clinical response to golimumab or placebo at Week 6 in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will not be randomly assigned but will be eligible to be enrolled in the study (i.e., the nonrandomized group) and received the following treatment regimens: placebo, golimumab 100 mg and golimumab 100 mg. Dose adjustment will be done for participants who were in clinical response to golimumab or placebo during induction studies C0524T16 (NCT00488774) or C0524T17 (NCT00487539) but lose clinical response during maintenance study C0524T18 (NCT00488631). On completing this study, participant will have the opportunity to continue to receive study medication in a study extension that will last up to approximately 3 years. Efficacy will be primarily evaluated by assessing the clinical response using Mayo Score. Participants' safety will be monitored throughout the study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1228 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Study Start Date
:
Sep 1, 2007
Actual Primary Completion Date
:
Oct 1, 2011
Actual Study Completion Date
:
Feb 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Golimumab induction responders (GLM-I-Rsp)-Placebo Maintenance Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. |
Biological: Placebo
Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
Biological: Golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
|
| Experimental: GLM-I-Rsp-Golimumab 50 mg Maintenance Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52. |
Biological: Golimumab 50 mg
Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
Biological: Golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
|
| Experimental: GLM-I-Rsp-Golimumab 100 mg Maintenance Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52. |
Biological: Golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
Biological: Golimumab 200 mg
Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52.
|
| Placebo Comparator: Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. |
Biological: Placebo
Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
Biological: Golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
|
| Experimental: PBO-I-nonRsp-Golimumab 100 mg Maintenance Participants not in clinical response to placebo at Week 6 induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. |
Biological: Golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
|
| Experimental: GLM-I-nonRsp-Golimumab 100 mg Maintenance Participants not in clinical response to golimumab at Week 6 of induction study and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. |
Biological: Golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants in Clinical Response Through Week 54 [Induction Baseline, Week 0 through Week 54]
Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (>=) 30 percent and >= 3, with either decrease from induction baseline in rectal bleeding subscore of >= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.
Secondary Outcome Measures
- Number of Participants With Clinical Remission at Both Week 30 and Week 54 [Week 30 and Week 54]
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
- Number of Participants With Mucosal Healing at Both Week 30 and Week 54 [Week 30 and Week 54]
Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported.
- Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study [Week 30 and Week 54]
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
- Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study [Week 54]
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants who received all study agent administrations and completed the Week 6 Mayo score evaluation in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
-
Participants who completed the Week 0 visit for this maintenance study C0524T18 (NCT00488631) on the same day as the Week 6 visit of the induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
Exclusion Criteria:
-
Participants who increased the dose of their concomitant (given at the same time) UC medications since Week 0 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
-
Participants who initiated a concomitant UC medication since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
-
Participants who had a partial or total colectomy (surgery to remove part or all of the colon) or an ostomy (surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent) since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
-
Participants with signs or symptoms of latent or active granulomatous infection (including TB); a nontuberculous mycobacterial infection or opportunistic infection; or infection with HIV (Human Immunodeficiency Virus), hepatitis B, or hepatitis C
-
Participants with signs and symptoms of any malignancy or suggestive of a possible lymphoproliferative disease (disorders characterized by proliferation of lymphoid tissue, general or unspecified)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | ||
| 2 | Little Rock | Arkansas | United States | ||
| 3 | Anaheim | California | United States | ||
| 4 | Merced | California | United States | ||
| 5 | Orange | California | United States | ||
| 6 | Roseville | California | United States | ||
| 7 | San Diego | California | United States | ||
| 8 | Lakewood | Colorado | United States | ||
| 9 | Littleton | Colorado | United States | ||
| 10 | Bristol | Connecticut | United States | ||
| 11 | Newark | Delaware | United States | ||
| 12 | Boca Raton | Florida | United States | ||
| 13 | Gainesville | Florida | United States | ||
| 14 | Hialeah | Florida | United States | ||
| 15 | Hollywood | Florida | United States | ||
| 16 | Jacksonville | Florida | United States | ||
| 17 | N Miami Beach | Florida | United States | ||
| 18 | Naples | Florida | United States | ||
| 19 | New Port Richey | Florida | United States | ||
| 20 | Port Orange | Florida | United States | ||
| 21 | Tampa | Florida | United States | ||
| 22 | Winter Park | Florida | United States | ||
| 23 | Zephyrhills | Florida | United States | ||
| 24 | Atlanta | Georgia | United States | ||
| 25 | Decatur | Georgia | United States | ||
| 26 | Savannah | Georgia | United States | ||
| 27 | Snellville | Georgia | United States | ||
| 28 | Arlington Heights | Illinois | United States | ||
| 29 | Chicago | Illinois | United States | ||
| 30 | Clive | Iowa | United States | ||
| 31 | Fort Dodge | Iowa | United States | ||
| 32 | Pratt | Kansas | United States | ||
| 33 | Topeka | Kansas | United States | ||
| 34 | Lexington | Kentucky | United States | ||
| 35 | Louisville | Kentucky | United States | ||
| 36 | Monroe | Louisiana | United States | ||
| 37 | Hagerstown | Maryland | United States | ||
| 38 | Hollywood | Maryland | United States | ||
| 39 | Laurel | Maryland | United States | ||
| 40 | Worcester | Massachusetts | United States | ||
| 41 | Ann Arbor | Michigan | United States | ||
| 42 | Dearborn | Michigan | United States | ||
| 43 | Troy | Michigan | United States | ||
| 44 | Plymouth | Minnesota | United States | ||
| 45 | Rochester | Minnesota | United States | ||
| 46 | Pascagoula | Mississippi | United States | ||
| 47 | Tupelo | Mississippi | United States | ||
| 48 | Urbana | Missouri | United States | ||
| 49 | Las Vegas | Nevada | United States | ||
| 50 | Lebanon | New Hampshire | United States | ||
| 51 | Egg Harbor Township | New Jersey | United States | ||
| 52 | Great Neck | New York | United States | ||
| 53 | Huntington | New York | United States | ||
| 54 | New York | New York | United States | ||
| 55 | Rochester | New York | United States | ||
| 56 | Asheville | North Carolina | United States | ||
| 57 | Boone | North Carolina | United States | ||
| 58 | Charlotte | North Carolina | United States | ||
| 59 | Harrisburg | North Carolina | United States | ||
| 60 | Kinston | North Carolina | United States | ||
| 61 | Morganton | North Carolina | United States | ||
| 62 | New Bern | North Carolina | United States | ||
| 63 | Raleigh | North Carolina | United States | ||
| 64 | Wilmington | North Carolina | United States | ||
| 65 | Winston Salem | North Carolina | United States | ||
| 66 | Fargo | North Dakota | United States | ||
| 67 | Cincinnati | Ohio | United States | ||
| 68 | Cleveland | Ohio | United States | ||
| 69 | Colombus | Ohio | United States | ||
| 70 | Norman | Oklahoma | United States | ||
| 71 | Oklahoma City | Oklahoma | United States | ||
| 72 | Tulsa | Oklahoma | United States | ||
| 73 | Portland | Oregon | United States | ||
| 74 | Limerick | Pennsylvania | United States | ||
| 75 | Philadelphia | Pennsylvania | United States | ||
| 76 | Charleston | South Carolina | United States | ||
| 77 | Columbia | South Carolina | United States | ||
| 78 | Germantown | Tennessee | United States | ||
| 79 | Nashville | Tennessee | United States | ||
| 80 | Austin | Texas | United States | ||
| 81 | Dallas | Texas | United States | ||
| 82 | Galveston | Texas | United States | ||
| 83 | Houston | Texas | United States | ||
| 84 | Logan | Utah | United States | ||
| 85 | Ogden | Utah | United States | ||
| 86 | Burlington | Vermont | United States | ||
| 87 | Chesapeake | Virginia | United States | ||
| 88 | Christiansburg | Virginia | United States | ||
| 89 | Fairfax | Virginia | United States | ||
| 90 | Richmond | Virginia | United States | ||
| 91 | Bellevue | Washington | United States | ||
| 92 | Seattle | Washington | United States | ||
| 93 | Spokane | Washington | United States | ||
| 94 | Tacoma | Washington | United States | ||
| 95 | Madison | Wisconsin | United States | ||
| 96 | Milwaukee | Wisconsin | United States | ||
| 97 | Adelaide | Australia | |||
| 98 | Bankstown | Australia | |||
| 99 | Box Hill | Australia | |||
| 100 | Brisbane | Australia | |||
| 101 | Cairns | Australia | |||
| 102 | Fitzroy | Australia | |||
| 103 | Fremantle | Australia | |||
| 104 | Herston | Australia | |||
| 105 | Launceston | Australia | |||
| 106 | Malvern | Australia | |||
| 107 | Parkville | Australia | |||
| 108 | Prahran | Australia | |||
| 109 | Westmead | Australia | |||
| 110 | Innsbruck | Austria | |||
| 111 | Wien N/A | Austria | |||
| 112 | Bonheiden | Belgium | |||
| 113 | Brussel | Belgium | |||
| 114 | Gent | Belgium | |||
| 115 | Leuven | Belgium | |||
| 116 | Liège | Belgium | |||
| 117 | Roeselare | Belgium | |||
| 118 | Bulgaria | Bulgaria | |||
| 119 | Pleven | Bulgaria | |||
| 120 | Plovdiv | Bulgaria | |||
| 121 | Rousse | Bulgaria | |||
| 122 | Sofia | Bulgaria | |||
| 123 | Calgary | Alberta | Canada | ||
| 124 | Vancouver | British Columbia | Canada | ||
| 125 | Victoria | British Columbia | Canada | ||
| 126 | Winnipeg | Manitoba | Canada | ||
| 127 | Barrie | Ontario | Canada | ||
| 128 | Chatham | Ontario | Canada | ||
| 129 | Hamilton | Ontario | Canada | ||
| 130 | Kingston | Ontario | Canada | ||
| 131 | London | Ontario | Canada | ||
| 132 | Vaughan | Ontario | Canada | ||
| 133 | Montreal | Quebec | Canada | ||
| 134 | Saskatoon | Saskatchewan | Canada | ||
| 135 | Quebec | Canada | |||
| 136 | Toronto | Canada | |||
| 137 | Windsor | Canada | |||
| 138 | Hradec Kralove | Czech Republic | |||
| 139 | Litomerice | Czech Republic | |||
| 140 | Ostrava | Czech Republic | |||
| 141 | Èeské Budìjovice 1 | Czech Republic | |||
| 142 | Aalborg | Denmark | |||
| 143 | Aarhus C. | Denmark | |||
| 144 | Hvidovre | Denmark | |||
| 145 | Odense C | Denmark | |||
| 146 | Amiens Cedex 1 80 | France | |||
| 147 | Bordeaux 33 | France | |||
| 148 | Clichy | France | |||
| 149 | Lille Cedex | France | |||
| 150 | Marseille Cedex 13 | France | |||
| 151 | Nice Cedex 3 | France | |||
| 152 | Paris | France | |||
| 153 | Rouen | France | |||
| 154 | Aachen | Germany | |||
| 155 | Berlin Be | Germany | |||
| 156 | Berlin | Germany | |||
| 157 | Bochum | Germany | |||
| 158 | Frankfurt | Germany | |||
| 159 | Hamburg | Germany | |||
| 160 | Hannover | Germany | |||
| 161 | Heidelberg | Germany | |||
| 162 | Herne | Germany | |||
| 163 | Jena | Germany | |||
| 164 | Kiel | Germany | |||
| 165 | Magdeburg | Germany | |||
| 166 | Minden | Germany | |||
| 167 | Muenchen | Germany | |||
| 168 | München | Germany | |||
| 169 | Münster | Germany | |||
| 170 | Neustadt | Germany | |||
| 171 | Stade | Germany | |||
| 172 | Balatonfured | Hungary | |||
| 173 | Budapest N/A | Hungary | |||
| 174 | Budapest | Hungary | |||
| 175 | Debrecen | Hungary | |||
| 176 | Dunaujvaros | Hungary | |||
| 177 | Gyulai Ut 18 | Hungary | |||
| 178 | Gyula | Hungary | |||
| 179 | Gyõr | Hungary | |||
| 180 | Miskolc | Hungary | |||
| 181 | Mosonmagyarovar | Hungary | |||
| 182 | Pécs | Hungary | |||
| 183 | Siofok | Hungary | |||
| 184 | Sopron | Hungary | |||
| 185 | Szeged | Hungary | |||
| 186 | Szekesfehervar | Hungary | |||
| 187 | Szekszard | Hungary | |||
| 188 | Szombathely | Hungary | |||
| 189 | Veszprém | Hungary | |||
| 190 | Zalaegerszeg | Hungary | |||
| 191 | Bangalore | India | |||
| 192 | Chennai | India | |||
| 193 | Hyderabad Andh Prad | India | |||
| 194 | Hyderabad | India | |||
| 195 | Jaipur | India | |||
| 196 | Karnad | India | |||
| 197 | Lucknow Gpo | India | |||
| 198 | Ludhiana | India | |||
| 199 | New Delhi | India | |||
| 200 | Pune | India | |||
| 201 | Vishakapatanam | India | |||
| 202 | Afula | Israel | |||
| 203 | Beer Sheva | Israel | |||
| 204 | Beer Yaakov | Israel | |||
| 205 | Haifa | Israel | |||
| 206 | Hedera | Israel | |||
| 207 | Jerusalem | Israel | |||
| 208 | Kfar Sava | Israel | |||
| 209 | Kiryat Bialik | Israel | |||
| 210 | Nazareth | Israel | |||
| 211 | Petah-Tikv | Israel | |||
| 212 | Rechovot | Israel | |||
| 213 | Tel Hashomer | Israel | |||
| 214 | Tel-Aviv | Israel | |||
| 215 | Bunkyo-Ku | Japan | |||
| 216 | Bunkyo | Japan | |||
| 217 | Chikushinoshi | Japan | |||
| 218 | Fukuoka | Japan | |||
| 219 | Hiroshima | Japan | |||
| 220 | Kagoshima | Japan | |||
| 221 | Kurashiki | Japan | |||
| 222 | Kurume | Japan | |||
| 223 | Nagoya | Japan | |||
| 224 | Nishinomiya | Japan | |||
| 225 | Okayama | Japan | |||
| 226 | Osaka | Japan | |||
| 227 | Sakura | Japan | |||
| 228 | Sapporo-Shi | Japan | |||
| 229 | Sapporo | Japan | |||
| 230 | Tokyo N/A | Japan | |||
| 231 | Tokyo | Japan | |||
| 232 | Yokkaichi | Japan | |||
| 233 | Balvi | Latvia | |||
| 234 | Daugavpils | Latvia | |||
| 235 | Riga | Latvia | |||
| 236 | Kaunas | Lithuania | |||
| 237 | Klaipeda | Lithuania | |||
| 238 | Siauliai | Lithuania | |||
| 239 | Vilnius Lt | Lithuania | |||
| 240 | Vilnius | Lithuania | |||
| 241 | Amsterdam | Netherlands | |||
| 242 | Ede Gld | Netherlands | |||
| 243 | Groningen | Netherlands | |||
| 244 | Leiden | Netherlands | |||
| 245 | Nieuwegein | Netherlands | |||
| 246 | Rotterdam | Netherlands | |||
| 247 | Auckland | New Zealand | |||
| 248 | Christchurch | New Zealand | |||
| 249 | Dunedin | New Zealand | |||
| 250 | Hamilton | New Zealand | |||
| 251 | Hastings | New Zealand | |||
| 252 | Bialystok N/A | Poland | |||
| 253 | Bydgoszcz N/A | Poland | |||
| 254 | Czestochowa | Poland | |||
| 255 | Elblag | Poland | |||
| 256 | Gdansk N/A | Poland | |||
| 257 | Gdansk | Poland | |||
| 258 | Krakow N/A | Poland | |||
| 259 | Krakow | Poland | |||
| 260 | Kraków N/A | Poland | |||
| 261 | Lodz | Poland | |||
| 262 | Lublin | Poland | |||
| 263 | Opole N/A | Poland | |||
| 264 | Skierniewice | Poland | |||
| 265 | Sopot | Poland | |||
| 266 | Szczecin | Poland | |||
| 267 | Torun | Poland | |||
| 268 | Warszawa N/A | Poland | |||
| 269 | Warszawa | Poland | |||
| 270 | Bucuresti | Romania | |||
| 271 | Cluj-Napoca | Romania | |||
| 272 | Iasi | Romania | |||
| 273 | Targu Mures | Romania | |||
| 274 | Timisoara | Romania | |||
| 275 | Moscow | Russian Federation | |||
| 276 | Novosibirsk | Russian Federation | |||
| 277 | Omsk | Russian Federation | |||
| 278 | Saint Petersburg | Russian Federation | |||
| 279 | Smolensk | Russian Federation | |||
| 280 | St Petersburg | Russian Federation | |||
| 281 | St-Petersburg | Russian Federation | |||
| 282 | Yaroslavl | Russian Federation | |||
| 283 | Belgrade | Serbia | |||
| 284 | Beograd | Serbia | |||
| 285 | Nis | Serbia | |||
| 286 | Zemun | Serbia | |||
| 287 | Bratislava | Slovakia | |||
| 288 | Martin | Slovakia | |||
| 289 | Nitra | Slovakia | |||
| 290 | Nove Mesto Nad Vahom | Slovakia | |||
| 291 | Presov | Slovakia | |||
| 292 | Trnava | Slovakia | |||
| 293 | Cape Town West Cape | South Africa | |||
| 294 | Cape Town | South Africa | |||
| 295 | Durban N/A | South Africa | |||
| 296 | Plumstead West Cape | South Africa | |||
| 297 | Pretoria Gauteng | South Africa | |||
| 298 | Göteborg | Sweden | |||
| 299 | Stockholm | Sweden | |||
| 300 | Donetsk | Ukraine | |||
| 301 | Ivano | Ukraine | |||
| 302 | Kharkiv | Ukraine | |||
| 303 | Kiev | Ukraine | |||
| 304 | Kyiv | Ukraine | |||
| 305 | Lviv | Ukraine | |||
| 306 | Poltava | Ukraine | |||
| 307 | Simferopol | Ukraine | |||
| 308 | Vinnitsa | Ukraine | |||
| 309 | Zhaporozhia 69104 | Ukraine |
Sponsors and Collaborators
- Janssen Research & Development, LLC
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00488631
Other Study ID Numbers:
- CR014179
- 2006-003399-37
- C0524T18
First Posted:
Jun 20, 2007
Last Update Posted:
Apr 26, 2016
Last Verified:
Mar 1, 2016
Keywords provided by Janssen Research & Development, LLC
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Efficacy results are based on participants who were Golimumab induction responders (GLM-I-Rsp) and were randomly assigned to GLM-I-Rsp-Placebo Maintenance, GLM-I-Rsp-Golimumab 50 mg and GLM-I-Rsp-Golimumab 100 mg as per planned analysis. |
| Arm/Group Title | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | GLM-I-Rsp-Golimumab 50 mg Maintenance | GLM-I-Rsp-Golimumab 100 mg Maintenance | Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance | PBO-I-nonRsp-Golimumab 100 mg Maintenance | GLM-I-nonRsp-Golimumab 100 mg Maintenance | Placebo Extension | Golimumab 50 mg - Extension | Golimumab 100 mg Extension | Golimumab 200 mg Extension |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. | Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment. | Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. | Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. | Participants entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension. | Participants entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks. | Participants entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks. | Participants entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks. |
| Period Title: Double Blind Period (Week 0-54) | ||||||||||
| STARTED | 156 | 154 | 154 | 129 | 230 | 405 | 0 | 0 | 0 | 0 |
| COMPLETED | 113 | 111 | 109 | 88 | 127 | 189 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 43 | 43 | 45 | 41 | 103 | 216 | 0 | 0 | 0 | 0 |
| Period Title: Double Blind Period (Week 0-54) | ||||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 96 | 93 | 470 | 7 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 16 | 66 | 288 | 4 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 80 | 27 | 182 | 3 |
Baseline Characteristics
| Arm/Group Title | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | GLM-I-Rsp-Golimumab 50 mg Maintenance | GLM-I-Rsp-Golimumab 100 mg Maintenance | Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance | PBO-I-nonRsp-Golimumab 100 mg Maintenance | GLM-I-nonRsp-Golimumab 100 mg Maintenance | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. | Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment. | Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. | Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. | Total of all reporting groups |
| Overall Participants | 156 | 154 | 154 | 129 | 230 | 405 | 1228 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
40.2
(14.05)
|
41.4
(13.84)
|
39.1
(13.11)
|
38
(13.27)
|
40.3
(12.67)
|
41.2
(13.6)
|
40.3
(13.44)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
81
51.9%
|
77
50%
|
65
42.2%
|
68
52.7%
|
99
43%
|
138
34.1%
|
528
43%
|
| Male |
75
48.1%
|
77
50%
|
89
57.8%
|
61
47.3%
|
131
57%
|
267
65.9%
|
700
57%
|
Outcome Measures
| Title | Number of Participants in Clinical Response Through Week 54 |
|---|---|
| Description | Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (>=) 30 percent and >= 3, with either decrease from induction baseline in rectal bleeding subscore of >= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12. |
| Time Frame | Induction Baseline, Week 0 through Week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | GLM-I-Rsp-Golimumab 50 mg Maintenance | GLM-I-Rsp-Golimumab 100 mg Maintenance |
|---|---|---|---|
| Arm/Group Description | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. |
| Measure Participants | 154 | 151 | 151 |
| Number [Participants] |
48
30.8%
|
71
46.1%
|
75
48.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance, GLM-I-Rsp-Golimumab 50 mg Maintenance |
|---|---|---|
| Comments | Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo). | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance, GLM-I-Rsp-Golimumab 100 mg Maintenance |
|---|---|---|
| Comments | Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo). | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Number of Participants With Clinical Remission at Both Week 30 and Week 54 |
|---|---|
| Description | Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported. |
| Time Frame | Week 30 and Week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | GLM-I-Rsp-Golimumab 50 mg Maintenance | GLM-I-Rsp-Golimumab 100 mg Maintenance |
|---|---|---|---|
| Arm/Group Description | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. |
| Measure Participants | 154 | 151 | 151 |
| Number [Participants] |
24
15.4%
|
35
22.7%
|
42
27.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance, GLM-I-Rsp-Golimumab 50 mg Maintenance |
|---|---|---|
| Comments | Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.122 |
| Comments | Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance, GLM-I-Rsp-Golimumab 100 mg Maintenance |
|---|---|---|
| Comments | Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Number of Participants With Mucosal Healing at Both Week 30 and Week 54 |
|---|---|
| Description | Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported. |
| Time Frame | Week 30 and Week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | GLM-I-Rsp-Golimumab 50 mg Maintenance | GLM-I-Rsp-Golimumab 100 mg Maintenance |
|---|---|---|---|
| Arm/Group Description | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. |
| Measure Participants | 154 | 151 | 151 |
| Number [Participants] |
41
26.3%
|
63
40.9%
|
64
41.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance, GLM-I-Rsp-Golimumab 50 mg Maintenance |
|---|---|---|
| Comments | Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.011 |
| Comments | Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance, GLM-I-Rsp-Golimumab 100 mg Maintenance |
|---|---|---|
| Comments | Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study |
|---|---|
| Description | Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported. |
| Time Frame | Week 30 and Week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included randomly assigned participants who were in clinical remission to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | GLM-I-Rsp-Golimumab 50 mg Maintenance | GLM-I-Rsp-Golimumab 100 mg Maintenance |
|---|---|---|---|
| Arm/Group Description | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. |
| Measure Participants | 54 | 52 | 54 |
| Number [Participants] |
13
8.3%
|
19
12.3%
|
21
13.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance, GLM-I-Rsp-Golimumab 50 mg Maintenance |
|---|---|---|
| Comments | Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.365 |
| Comments | Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance, GLM-I-Rsp-Golimumab 100 mg Maintenance |
|---|---|---|
| Comments | Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.098 |
| Comments | Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study |
|---|---|
| Description | Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. |
| Time Frame | Week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included randomly assigned participants in clinical response to golimumab induction who were receiving concomitant corticosteroids at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | GLM-I-Rsp-Golimumab 50 mg Maintenance | GLM-I-Rsp-Golimumab 100 mg Maintenance |
|---|---|---|---|
| Arm/Group Description | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. |
| Measure Participants | 87 | 78 | 82 |
| Number [Participants] |
16
10.3%
|
22
14.3%
|
19
12.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance, GLM-I-Rsp-Golimumab 50 mg Maintenance |
|---|---|---|
| Comments | Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.279 |
| Comments | Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance, GLM-I-Rsp-Golimumab 100 mg Maintenance |
|---|---|---|
| Comments | Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.423 |
| Comments | Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Adverse Events
| Time Frame | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||||||||||||||||||||
| Arm/Group Title | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | GLM-I-Rsp-Golimumab 50 mg Maintenance | GLM-I-Rsp-Golimumab 100 mg Maintenance | GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg | GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg | GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg | Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance | PBO-I-nonRsp-Golimumab 100 mg Maintenance | GLM-I-nonRsp-Golimumab 100 mg Maintenance | PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg | Placebo Extension | Golimumab 50 mg Extension Phase | Golimumab 100 mg Extension | Golimumab 200 mg Extension | Placebo - 50 mg Extension | Placebo - Golimumab100 mg Extension | Golimumab 50 mg - 100 mg Extension | Golimumab 100 mg - 200 mg Extension | ||||||||||||||||||
| Arm/Group Description | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Adverse events are presented through Week 54.Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54. | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 200 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response. Adverse events are presented from the time of dose adjustment onwards up to Week 54. | Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment. | Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54. | Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54. | Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631) and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 on loss of clinical response; not randomized. Adverse events are presented from the time of dose adjustment onwards up to Week 54. | Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose. | Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose. | Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose. | Participants entered the study extension receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining golimumab 200 mg had their dose descreased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54. | A single participant entered the study extension receiving placebo subcutaneous injection administered every 4 weeks; and on worsening of UC disease had their dose increased to golimumab 50 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from the time of dose adjustment. | Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease in the study extension. Adverse events are presented from the time of dose adjustment. | Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment | Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment. | ||||||||||||||||||
All Cause Mortality |
||||||||||||||||||||||||||||||||||||
| Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | GLM-I-Rsp-Golimumab 50 mg Maintenance | GLM-I-Rsp-Golimumab 100 mg Maintenance | GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg | GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg | GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg | Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance | PBO-I-nonRsp-Golimumab 100 mg Maintenance | GLM-I-nonRsp-Golimumab 100 mg Maintenance | PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg | Placebo Extension | Golimumab 50 mg Extension Phase | Golimumab 100 mg Extension | Golimumab 200 mg Extension | Placebo - 50 mg Extension | Placebo - Golimumab100 mg Extension | Golimumab 50 mg - 100 mg Extension | Golimumab 100 mg - 200 mg Extension | |||||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||||||||||||||
| Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | GLM-I-Rsp-Golimumab 50 mg Maintenance | GLM-I-Rsp-Golimumab 100 mg Maintenance | GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg | GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg | GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg | Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance | PBO-I-nonRsp-Golimumab 100 mg Maintenance | GLM-I-nonRsp-Golimumab 100 mg Maintenance | PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg | Placebo Extension | Golimumab 50 mg Extension Phase | Golimumab 100 mg Extension | Golimumab 200 mg Extension | Placebo - 50 mg Extension | Placebo - Golimumab100 mg Extension | Golimumab 50 mg - 100 mg Extension | Golimumab 100 mg - 200 mg Extension | |||||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/156 (7.7%) | 13/154 (8.4%) | 22/154 (14.3%) | 8/76 (10.5%) | 6/25 (24%) | 1/14 (7.1%) | 7/129 (5.4%) | 34/230 (14.8%) | 63/405 (15.6%) | 7/56 (12.5%) | 8/96 (8.3%) | 11/93 (11.8%) | 91/469 (19.4%) | 1/7 (14.3%) | 0/1 (0%) | 7/28 (25%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||||||||||||||||
| Anaemia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 1/25 (4%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 1/405 (0.2%) | 0/56 (0%) | 1/96 (1%) | 1/93 (1.1%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Anaemia of Chronic Disease | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Aplastic Anaemia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Haemolytic Anaemia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Iron Deficiency Anaemia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Lymphadenopathy | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Thrombocytosis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Cardiac disorders | ||||||||||||||||||||||||||||||||||||
| Acute Myocardial Infarction | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Angina Pectoris | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 2/405 (0.5%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Atrial Fibrillation | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Cardiac Failure | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 1/96 (1%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Coronary Artery Disease | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Myocardial Infarction | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 2/96 (2.1%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pericarditis | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Endocrine disorders | ||||||||||||||||||||||||||||||||||||
| Autoimmune Thyroiditis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Eye disorders | ||||||||||||||||||||||||||||||||||||
| Blindness | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Cataract | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Macular Fibrosis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||||||||||||||||
| Abdominal Hernia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Abdominal Pain | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Anal Fissure | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Colitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Colitis Ulcerative | 3/156 (1.9%) | 3/154 (1.9%) | 6/154 (3.9%) | 6/76 (7.9%) | 3/25 (12%) | 0/14 (0%) | 3/129 (2.3%) | 13/230 (5.7%) | 43/405 (10.6%) | 4/56 (7.1%) | 1/96 (1%) | 2/93 (2.2%) | 18/469 (3.8%) | 0/7 (0%) | 0/1 (0%) | 2/28 (7.1%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Colon Dysplasia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Crohn's Disease | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Diarrhoea | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Enterocolitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Frequent Bowel Movements | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 1/25 (4%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Gastrooesophageal Reflux Disease | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Haemorrhoidal Haemorrhage | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 1/76 (1.3%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Haemorrhoids | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Ileus | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Inguinal Hernia | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Large Intestinal Stenosis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Large Intestine Polyp | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 3/469 (0.6%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Nausea | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pancreatitis | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pancreatitis Acute | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Small Intestinal Obstruction | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Volvulus of Small Bowel | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Vomiting | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| General disorders | ||||||||||||||||||||||||||||||||||||
| Chest Pain | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 3/469 (0.6%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Non-Cardiac Chest Pain | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Polyserositis | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pyrexia | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Hepatobiliary disorders | ||||||||||||||||||||||||||||||||||||
| Bile Duct Stone | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Cholecystitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Cholecystitis Chronic | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Cholestasis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Drug-Induced Liver Injury | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Hepatitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Hyperbilirubinaemia | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Infections and infestations | ||||||||||||||||||||||||||||||||||||
| Abscess Intestinal | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Anal Abscess | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 1/25 (4%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 3/469 (0.6%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Appendicitis | 0/156 (0%) | 0/154 (0%) | 3/154 (1.9%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Bacterial Sepsis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Brain Abscess | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Bronchitis | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 1/56 (1.8%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Clostridium Difficile Infection | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Conjunctivitis | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Cytomegalovirus Infection | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Disseminated Tuberculosis | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 2/405 (0.5%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Encephalitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Escherichia Pyelonephritis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Extrapulmonary Tuberculosis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Gastroenteritis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Gastroenteritis Rotavirus | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Hepatitis A | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Herpes Zoster | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Infected Cyst | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Infectious Colitis | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Lobar Pneumonia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Meningitis Viral | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Otitis Externa | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pelvic Sepsis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pilonidal Cyst | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pneumonia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 1/76 (1.3%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 1/96 (1%) | 1/93 (1.1%) | 6/469 (1.3%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pneumonia Legionella | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Postoperative Abscess | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pulmonary Tuberculosis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pyelonephritis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Respiratory Tract Infection Viral | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Sepsis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Septic Shock | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Sinusitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Staphylococcal Bacteraemia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Staphylococcal Infection | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Streptococcal Sepsis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Subcutaneous Abscess | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Tick-Borne Viral Encephalitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Urinary Tract Infection | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Viral Infection | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 1/25 (4%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||||||||||||||
| Accidental Overdose | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Accidental Poisoning | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Ankle Fracture | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Contusion | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Incisional Hernia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Intentional Overdose | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Laceration | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Meniscus Injury | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Penetrating Abdominal Trauma | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Post Procedural Complication | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 2/405 (0.5%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Seroma | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Spondylopathy Traumatic | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Tendon Rupture | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 1/96 (1%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Thoracic Vertebral Fracture | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 1/96 (1%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Vascular Pseudoaneurysm | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Wrist Fracture | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Investigations | ||||||||||||||||||||||||||||||||||||
| Liver Function Test Abnormal | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||||||||||||||||||
| Dehydration | 1/156 (0.6%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Diabetes Mellitus | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Hyponatraemia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Malnutrition | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||||||||||||||
| Arthralgia | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Back Pain | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Bursitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 1/56 (1.8%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Intervertebral Disc Protrusion | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Musculoskeletal Pain | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Osteoarthritis | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Osteonecrosis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Seronegative Arthritis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||||||||||||||||
| Adrenal Adenoma | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Basal Cell Carcinoma | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Breast Cancer | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Colon Adenoma | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Colon Cancer Metastatic | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Gallbladder Cancer | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Hodgkin's Disease | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Huerthle Cell Carcinoma | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Lung Adenocarcinoma | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Ovarian Cancer | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Ovarian Epithelial Cancer | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Prostate Cancer | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Rectal Adenocarcinoma | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Rectal Cancer Metastatic | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Renal Cancer Metastatic | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| T-Cell Lymphoma | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Uterine Leiomyoma | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Nervous system disorders | ||||||||||||||||||||||||||||||||||||
| Carotid Artery Stenosis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Convulsion | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Demyelination | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Facial Paresis | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Loss of Consciousness | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Multiple Sclerosis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Nerve Root Compression | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Sciatica | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Syncope | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Transient Ischaemic Attack | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 1/96 (1%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||||||||||||||||||||||||||
| Abortion Spontaneous | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pregnancy | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Psychiatric disorders | ||||||||||||||||||||||||||||||||||||
| Depression | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Depression Suicidal | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Depressive Symptom | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Mental Disorder | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Substance Abuse | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Renal and urinary disorders | ||||||||||||||||||||||||||||||||||||
| Bladder Neck Obstruction | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 1/96 (1%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Nephrolithiasis | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pelvi-Ureteric Obstruction | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Renal Colic | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Renal Failure Acute | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||||||||||||||||||
| Benign Prostatic Hyperplasia | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Cervical Dysplasia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Uterine Polyp | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Uterine Prolapse | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Vaginal Prolapse | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||||||||||
| Aspiration | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Interstitial Lung Disease | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Lung Infiltration | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pleural Effusion | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pneumonitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pulmonary Embolism | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Respiratory Failure | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||||||||||||
| Dermatitis Allergic | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Drug Eruption | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 1/56 (1.8%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Hypersensitivity Vasculitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Lichen Sclerosus | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pyoderma Gangrenosum | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Rash | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Vascular disorders | ||||||||||||||||||||||||||||||||||||
| Aortic Aneurysm Rupture | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Deep Vein Thrombosis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Hypertension | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Thrombophlebitis Superficial | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||||||||||||||
| Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | GLM-I-Rsp-Golimumab 50 mg Maintenance | GLM-I-Rsp-Golimumab 100 mg Maintenance | GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg | GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg | GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg | Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance | PBO-I-nonRsp-Golimumab 100 mg Maintenance | GLM-I-nonRsp-Golimumab 100 mg Maintenance | PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg | Placebo Extension | Golimumab 50 mg Extension Phase | Golimumab 100 mg Extension | Golimumab 200 mg Extension | Placebo - 50 mg Extension | Placebo - Golimumab100 mg Extension | Golimumab 50 mg - 100 mg Extension | Golimumab 100 mg - 200 mg Extension | |||||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 88/156 (56.4%) | 102/154 (66.2%) | 94/154 (61%) | 44/76 (57.9%) | 15/25 (60%) | 10/14 (71.4%) | 67/129 (51.9%) | 140/230 (60.9%) | 247/405 (61%) | 30/56 (53.6%) | 43/96 (44.8%) | 58/93 (62.4%) | 329/469 (70.1%) | 6/7 (85.7%) | 1/1 (100%) | 19/28 (67.9%) | 11/19 (57.9%) | 7/10 (70%) | ||||||||||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||||||||||||||||
| Anaemia | 1/156 (0.6%) | 4/154 (2.6%) | 5/154 (3.2%) | 2/76 (2.6%) | 1/25 (4%) | 0/14 (0%) | 2/129 (1.6%) | 10/230 (4.3%) | 22/405 (5.4%) | 1/56 (1.8%) | 2/96 (2.1%) | 1/93 (1.1%) | 20/469 (4.3%) | 1/7 (14.3%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Eosinophilia | 1/156 (0.6%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 2/230 (0.9%) | 3/405 (0.7%) | 1/56 (1.8%) | 0/96 (0%) | 2/93 (2.2%) | 7/469 (1.5%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Leukopenia | 2/156 (1.3%) | 2/154 (1.3%) | 5/154 (3.2%) | 0/76 (0%) | 2/25 (8%) | 0/14 (0%) | 1/129 (0.8%) | 0/230 (0%) | 7/405 (1.7%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||||||||||||||||||
| Ear Pain | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 1/230 (0.4%) | 2/405 (0.5%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 4/469 (0.9%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Eye disorders | ||||||||||||||||||||||||||||||||||||
| Dry Eye | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Eye Irritation | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Myopia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Ocular Hyperaemia | 1/156 (0.6%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Vision Blurred | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||||||||||||||||
| Abdominal Discomfort | 0/156 (0%) | 0/154 (0%) | 2/154 (1.3%) | 2/76 (2.6%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 0/230 (0%) | 3/405 (0.7%) | 0/56 (0%) | 1/96 (1%) | 1/93 (1.1%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Abdominal Pain | 4/156 (2.6%) | 10/154 (6.5%) | 11/154 (7.1%) | 3/76 (3.9%) | 2/25 (8%) | 0/14 (0%) | 5/129 (3.9%) | 9/230 (3.9%) | 21/405 (5.2%) | 0/56 (0%) | 4/96 (4.2%) | 6/93 (6.5%) | 28/469 (6%) | 0/7 (0%) | 1/1 (100%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Abdominal Pain Upper | 1/156 (0.6%) | 4/154 (2.6%) | 1/154 (0.6%) | 1/76 (1.3%) | 0/25 (0%) | 1/14 (7.1%) | 2/129 (1.6%) | 2/230 (0.9%) | 6/405 (1.5%) | 0/56 (0%) | 1/96 (1%) | 3/93 (3.2%) | 11/469 (2.3%) | 0/7 (0%) | 1/1 (100%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Colitis Ulcerative | 29/156 (18.6%) | 25/154 (16.2%) | 18/154 (11.7%) | 7/76 (9.2%) | 2/25 (8%) | 1/14 (7.1%) | 17/129 (13.2%) | 25/230 (10.9%) | 49/405 (12.1%) | 7/56 (12.5%) | 20/96 (20.8%) | 17/93 (18.3%) | 111/469 (23.7%) | 2/7 (28.6%) | 0/1 (0%) | 7/28 (25%) | 2/19 (10.5%) | 3/10 (30%) | ||||||||||||||||||
| Constipation | 1/156 (0.6%) | 2/154 (1.3%) | 3/154 (1.9%) | 1/76 (1.3%) | 0/25 (0%) | 0/14 (0%) | 2/129 (1.6%) | 5/230 (2.2%) | 6/405 (1.5%) | 0/56 (0%) | 0/96 (0%) | 4/93 (4.3%) | 11/469 (2.3%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 1/19 (5.3%) | 1/10 (10%) | ||||||||||||||||||
| Dental Caries | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 1/405 (0.2%) | 1/56 (1.8%) | 1/96 (1%) | 0/93 (0%) | 3/469 (0.6%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Diarrhoea | 7/156 (4.5%) | 4/154 (2.6%) | 5/154 (3.2%) | 4/76 (5.3%) | 2/25 (8%) | 1/14 (7.1%) | 2/129 (1.6%) | 3/230 (1.3%) | 7/405 (1.7%) | 1/56 (1.8%) | 4/96 (4.2%) | 7/93 (7.5%) | 32/469 (6.8%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 2/10 (20%) | ||||||||||||||||||
| Dyspepsia | 2/156 (1.3%) | 3/154 (1.9%) | 2/154 (1.3%) | 1/76 (1.3%) | 0/25 (0%) | 0/14 (0%) | 3/129 (2.3%) | 4/230 (1.7%) | 2/405 (0.5%) | 1/56 (1.8%) | 1/96 (1%) | 1/93 (1.1%) | 14/469 (3%) | 1/7 (14.3%) | 0/1 (0%) | 1/28 (3.6%) | 2/19 (10.5%) | 0/10 (0%) | ||||||||||||||||||
| Flatulence | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 2/405 (0.5%) | 0/56 (0%) | 1/96 (1%) | 0/93 (0%) | 3/469 (0.6%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Haematochezia | 2/156 (1.3%) | 1/154 (0.6%) | 5/154 (3.2%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 5/129 (3.9%) | 1/230 (0.4%) | 4/405 (1%) | 0/56 (0%) | 2/96 (2.1%) | 3/93 (3.2%) | 10/469 (2.1%) | 0/7 (0%) | 1/1 (100%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Haemorrhoids | 2/156 (1.3%) | 3/154 (1.9%) | 3/154 (1.9%) | 1/76 (1.3%) | 1/25 (4%) | 1/14 (7.1%) | 3/129 (2.3%) | 4/230 (1.7%) | 7/405 (1.7%) | 0/56 (0%) | 2/96 (2.1%) | 3/93 (3.2%) | 13/469 (2.8%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Inguinal Hernia | 0/156 (0%) | 1/154 (0.6%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 3/469 (0.6%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Nausea | 3/156 (1.9%) | 7/154 (4.5%) | 7/154 (4.5%) | 1/76 (1.3%) | 2/25 (8%) | 1/14 (7.1%) | 6/129 (4.7%) | 3/230 (1.3%) | 16/405 (4%) | 1/56 (1.8%) | 4/96 (4.2%) | 2/93 (2.2%) | 19/469 (4.1%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Vomiting | 5/156 (3.2%) | 2/154 (1.3%) | 3/154 (1.9%) | 1/76 (1.3%) | 1/25 (4%) | 0/14 (0%) | 1/129 (0.8%) | 1/230 (0.4%) | 7/405 (1.7%) | 0/56 (0%) | 3/96 (3.1%) | 0/93 (0%) | 15/469 (3.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| General disorders | ||||||||||||||||||||||||||||||||||||
| Chest Pain | 0/156 (0%) | 0/154 (0%) | 2/154 (1.3%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 2/230 (0.9%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 2/93 (2.2%) | 6/469 (1.3%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Fatigue | 4/156 (2.6%) | 4/154 (2.6%) | 6/154 (3.9%) | 2/76 (2.6%) | 0/25 (0%) | 0/14 (0%) | 5/129 (3.9%) | 6/230 (2.6%) | 4/405 (1%) | 3/56 (5.4%) | 1/96 (1%) | 2/93 (2.2%) | 12/469 (2.6%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Feeling Cold | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Influenza Like Illness | 1/156 (0.6%) | 2/154 (1.3%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 5/230 (2.2%) | 6/405 (1.5%) | 1/56 (1.8%) | 1/96 (1%) | 2/93 (2.2%) | 6/469 (1.3%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Injection Site Erythema | 1/156 (0.6%) | 1/154 (0.6%) | 4/154 (2.6%) | 3/76 (3.9%) | 0/25 (0%) | 1/14 (7.1%) | 1/129 (0.8%) | 3/230 (1.3%) | 5/405 (1.2%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 7/469 (1.5%) | 1/7 (14.3%) | 0/1 (0%) | 2/28 (7.1%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Injection Site Induration | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Injection Site Oedema | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Injection Site Rash | 0/156 (0%) | 1/154 (0.6%) | 2/154 (1.3%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Oedema Peripheral | 1/156 (0.6%) | 3/154 (1.9%) | 4/154 (2.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 2/230 (0.9%) | 2/405 (0.5%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 6/469 (1.3%) | 1/7 (14.3%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pain | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 4/405 (1%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Pyrexia | 7/156 (4.5%) | 6/154 (3.9%) | 3/154 (1.9%) | 2/76 (2.6%) | 4/25 (16%) | 1/14 (7.1%) | 1/129 (0.8%) | 9/230 (3.9%) | 16/405 (4%) | 1/56 (1.8%) | 3/96 (3.1%) | 7/93 (7.5%) | 31/469 (6.6%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Immune system disorders | ||||||||||||||||||||||||||||||||||||
| Drug Hypersensitivity | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Seasonal Allergy | 3/156 (1.9%) | 2/154 (1.3%) | 1/154 (0.6%) | 1/76 (1.3%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 0/230 (0%) | 4/405 (1%) | 1/56 (1.8%) | 0/96 (0%) | 3/93 (3.2%) | 11/469 (2.3%) | 1/7 (14.3%) | 0/1 (0%) | 1/28 (3.6%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Infections and infestations | ||||||||||||||||||||||||||||||||||||
| Acute Tonsillitis | 0/156 (0%) | 2/154 (1.3%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Bronchitis | 3/156 (1.9%) | 6/154 (3.9%) | 1/154 (0.6%) | 1/76 (1.3%) | 0/25 (0%) | 0/14 (0%) | 2/129 (1.6%) | 1/230 (0.4%) | 10/405 (2.5%) | 2/56 (3.6%) | 1/96 (1%) | 4/93 (4.3%) | 21/469 (4.5%) | 0/7 (0%) | 0/1 (0%) | 3/28 (10.7%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Chlamydial Infection | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Clostridium Difficile Infection | 2/156 (1.3%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 3/405 (0.7%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 3/469 (0.6%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Conjunctivitis | 1/156 (0.6%) | 1/154 (0.6%) | 1/154 (0.6%) | 0/76 (0%) | 1/25 (4%) | 1/14 (7.1%) | 0/129 (0%) | 4/230 (1.7%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 3/93 (3.2%) | 5/469 (1.1%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Eyelid Infection | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Fungal Infection | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 3/230 (1.3%) | 0/405 (0%) | 0/56 (0%) | 1/96 (1%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Gastroenteritis | 3/156 (1.9%) | 2/154 (1.3%) | 3/154 (1.9%) | 2/76 (2.6%) | 0/25 (0%) | 0/14 (0%) | 2/129 (1.6%) | 4/230 (1.7%) | 4/405 (1%) | 1/56 (1.8%) | 0/96 (0%) | 5/93 (5.4%) | 23/469 (4.9%) | 0/7 (0%) | 0/1 (0%) | 2/28 (7.1%) | 0/19 (0%) | 2/10 (20%) | ||||||||||||||||||
| Gastroenteritis Viral | 0/156 (0%) | 2/154 (1.3%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 2/129 (1.6%) | 3/230 (1.3%) | 4/405 (1%) | 0/56 (0%) | 0/96 (0%) | 2/93 (2.2%) | 8/469 (1.7%) | 2/7 (28.6%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Giardiasis | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Herpes Zoster | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 4/230 (1.7%) | 2/405 (0.5%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 14/469 (3%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Hordeolum | 1/156 (0.6%) | 2/154 (1.3%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 2/129 (1.6%) | 3/230 (1.3%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 5/469 (1.1%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Influenza | 4/156 (2.6%) | 7/154 (4.5%) | 2/154 (1.3%) | 1/76 (1.3%) | 0/25 (0%) | 0/14 (0%) | 7/129 (5.4%) | 7/230 (3%) | 10/405 (2.5%) | 1/56 (1.8%) | 3/96 (3.1%) | 9/93 (9.7%) | 37/469 (7.9%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Labyrinthitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Nasopharyngitis | 10/156 (6.4%) | 14/154 (9.1%) | 23/154 (14.9%) | 7/76 (9.2%) | 4/25 (16%) | 3/14 (21.4%) | 5/129 (3.9%) | 17/230 (7.4%) | 33/405 (8.1%) | 3/56 (5.4%) | 5/96 (5.2%) | 10/93 (10.8%) | 77/469 (16.4%) | 2/7 (28.6%) | 1/1 (100%) | 4/28 (14.3%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Oral Herpes | 3/156 (1.9%) | 2/154 (1.3%) | 2/154 (1.3%) | 2/76 (2.6%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 3/230 (1.3%) | 6/405 (1.5%) | 1/56 (1.8%) | 1/96 (1%) | 1/93 (1.1%) | 21/469 (4.5%) | 1/7 (14.3%) | 0/1 (0%) | 2/28 (7.1%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Paronychia | 0/156 (0%) | 1/154 (0.6%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pharyngitis | 4/156 (2.6%) | 7/154 (4.5%) | 5/154 (3.2%) | 2/76 (2.6%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 7/230 (3%) | 6/405 (1.5%) | 0/56 (0%) | 1/96 (1%) | 6/93 (6.5%) | 23/469 (4.9%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Sinusitis | 3/156 (1.9%) | 6/154 (3.9%) | 6/154 (3.9%) | 1/76 (1.3%) | 1/25 (4%) | 0/14 (0%) | 3/129 (2.3%) | 5/230 (2.2%) | 9/405 (2.2%) | 1/56 (1.8%) | 3/96 (3.1%) | 5/93 (5.4%) | 42/469 (9%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Skin Infection | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 2/469 (0.4%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Tinea Cruris | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Tonsillitis | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 1/76 (1.3%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 1/230 (0.4%) | 1/405 (0.2%) | 1/56 (1.8%) | 1/96 (1%) | 2/93 (2.2%) | 4/469 (0.9%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Tooth Abscess | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 2/25 (8%) | 0/14 (0%) | 1/129 (0.8%) | 1/230 (0.4%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 5/469 (1.1%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Upper Respiratory Tract Infection | 4/156 (2.6%) | 8/154 (5.2%) | 8/154 (5.2%) | 6/76 (7.9%) | 3/25 (12%) | 1/14 (7.1%) | 6/129 (4.7%) | 16/230 (7%) | 20/405 (4.9%) | 4/56 (7.1%) | 4/96 (4.2%) | 6/93 (6.5%) | 39/469 (8.3%) | 1/7 (14.3%) | 0/1 (0%) | 2/28 (7.1%) | 2/19 (10.5%) | 2/10 (20%) | ||||||||||||||||||
| Urinary Tract Infection | 4/156 (2.6%) | 3/154 (1.9%) | 1/154 (0.6%) | 2/76 (2.6%) | 0/25 (0%) | 1/14 (7.1%) | 4/129 (3.1%) | 2/230 (0.9%) | 2/405 (0.5%) | 1/56 (1.8%) | 2/96 (2.1%) | 2/93 (2.2%) | 14/469 (3%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Viral Infection | 0/156 (0%) | 2/154 (1.3%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 3/230 (1.3%) | 4/405 (1%) | 2/56 (3.6%) | 2/96 (2.1%) | 3/93 (3.2%) | 9/469 (1.9%) | 1/7 (14.3%) | 0/1 (0%) | 1/28 (3.6%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Viral Pharyngitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 1/76 (1.3%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Viral Upper Respiratory Tract Infection | 0/156 (0%) | 1/154 (0.6%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 2/14 (14.3%) | 0/129 (0%) | 4/230 (1.7%) | 4/405 (1%) | 0/56 (0%) | 1/96 (1%) | 1/93 (1.1%) | 11/469 (2.3%) | 2/7 (28.6%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Vulvovaginal Candidiasis | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 2/230 (0.9%) | 1/405 (0.2%) | 1/56 (1.8%) | 0/96 (0%) | 1/93 (1.1%) | 4/469 (0.9%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Vulvovaginal Mycotic Infection | 1/156 (0.6%) | 3/154 (1.9%) | 1/154 (0.6%) | 1/76 (1.3%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 4/469 (0.9%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||||||||||||||
| Animal Bite | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 2/405 (0.5%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Arthropod Bite | 2/156 (1.3%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 2/93 (2.2%) | 3/469 (0.6%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Bite | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 1/1 (100%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Hand Fracture | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Joint Dislocation | 0/156 (0%) | 0/154 (0%) | 2/154 (1.3%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Ligament Sprain | 2/156 (1.3%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 3/405 (0.7%) | 0/56 (0%) | 2/96 (2.1%) | 0/93 (0%) | 5/469 (1.1%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Limb Fracture | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Toxicity to Various Agents | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Investigations | ||||||||||||||||||||||||||||||||||||
| Alanine Aminotransferase Increased | 1/156 (0.6%) | 3/154 (1.9%) | 3/154 (1.9%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 3/129 (2.3%) | 6/230 (2.6%) | 6/405 (1.5%) | 0/56 (0%) | 0/96 (0%) | 2/93 (2.2%) | 7/469 (1.5%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Aspartate Aminotransferase Increased | 1/156 (0.6%) | 5/154 (3.2%) | 2/154 (1.3%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 2/129 (1.6%) | 2/230 (0.9%) | 4/405 (1%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 6/469 (1.3%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Blood Calcium Increased | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Blood Creatinine Increased | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 2/469 (0.4%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Blood Parathyroid Hormone Increased | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Haemoglobin Decreased | 1/156 (0.6%) | 1/154 (0.6%) | 0/154 (0%) | 2/76 (2.6%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 1/56 (1.8%) | 0/96 (0%) | 0/93 (0%) | 4/469 (0.9%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Neutrophil Count Increased | 0/156 (0%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Vitamin D Decreased | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| White Blood Cell Count Increased | 0/156 (0%) | 2/154 (1.3%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 1/230 (0.4%) | 2/405 (0.5%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||||||||||||||||||
| Dehydration | 0/156 (0%) | 0/154 (0%) | 2/154 (1.3%) | 1/76 (1.3%) | 1/25 (4%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 1/405 (0.2%) | 1/56 (1.8%) | 1/96 (1%) | 1/93 (1.1%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 1/10 (10%) | ||||||||||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||||||||||||||
| Arthralgia | 11/156 (7.1%) | 11/154 (7.1%) | 9/154 (5.8%) | 7/76 (9.2%) | 0/25 (0%) | 1/14 (7.1%) | 7/129 (5.4%) | 11/230 (4.8%) | 29/405 (7.2%) | 2/56 (3.6%) | 5/96 (5.2%) | 9/93 (9.7%) | 24/469 (5.1%) | 0/7 (0%) | 0/1 (0%) | 3/28 (10.7%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Back Pain | 4/156 (2.6%) | 3/154 (1.9%) | 7/154 (4.5%) | 1/76 (1.3%) | 0/25 (0%) | 1/14 (7.1%) | 5/129 (3.9%) | 6/230 (2.6%) | 10/405 (2.5%) | 1/56 (1.8%) | 1/96 (1%) | 2/93 (2.2%) | 30/469 (6.4%) | 0/7 (0%) | 0/1 (0%) | 2/28 (7.1%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Muscle Spasms | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 3/230 (1.3%) | 4/405 (1%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 3/469 (0.6%) | 1/7 (14.3%) | 0/1 (0%) | 2/28 (7.1%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pain in Extremity | 4/156 (2.6%) | 3/154 (1.9%) | 1/154 (0.6%) | 1/76 (1.3%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 5/230 (2.2%) | 2/405 (0.5%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 7/469 (1.5%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Rotator Cuff Syndrome | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Spinal Osteoarthritis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Nervous system disorders | ||||||||||||||||||||||||||||||||||||
| Demyelination | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Headache | 14/156 (9%) | 13/154 (8.4%) | 12/154 (7.8%) | 8/76 (10.5%) | 2/25 (8%) | 2/14 (14.3%) | 6/129 (4.7%) | 22/230 (9.6%) | 25/405 (6.2%) | 3/56 (5.4%) | 1/96 (1%) | 6/93 (6.5%) | 36/469 (7.7%) | 1/7 (14.3%) | 1/1 (100%) | 2/28 (7.1%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Hyperaesthesia | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Migraine | 1/156 (0.6%) | 3/154 (1.9%) | 0/154 (0%) | 1/76 (1.3%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 4/230 (1.7%) | 1/405 (0.2%) | 1/56 (1.8%) | 1/96 (1%) | 0/93 (0%) | 2/469 (0.4%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Psychiatric disorders | ||||||||||||||||||||||||||||||||||||
| Anxiety | 1/156 (0.6%) | 2/154 (1.3%) | 2/154 (1.3%) | 1/76 (1.3%) | 0/25 (0%) | 0/14 (0%) | 2/129 (1.6%) | 2/230 (0.9%) | 3/405 (0.7%) | 0/56 (0%) | 2/96 (2.1%) | 0/93 (0%) | 12/469 (2.6%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Depression | 1/156 (0.6%) | 3/154 (1.9%) | 3/154 (1.9%) | 1/76 (1.3%) | 0/25 (0%) | 1/14 (7.1%) | 4/129 (3.1%) | 0/230 (0%) | 5/405 (1.2%) | 1/56 (1.8%) | 0/96 (0%) | 1/93 (1.1%) | 10/469 (2.1%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Insomnia | 2/156 (1.3%) | 1/154 (0.6%) | 2/154 (1.3%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 2/129 (1.6%) | 5/230 (2.2%) | 10/405 (2.5%) | 1/56 (1.8%) | 2/96 (2.1%) | 1/93 (1.1%) | 8/469 (1.7%) | 1/7 (14.3%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Renal and urinary disorders | ||||||||||||||||||||||||||||||||||||
| Dysuria | 0/156 (0%) | 0/154 (0%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 1/230 (0.4%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Micturition Urgency | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Pollakiuria | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 2/230 (0.9%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Renal Colic | 0/156 (0%) | 1/154 (0.6%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 1/28 (3.6%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||||||||||||||||||
| Cervix Haemorrhage Uterine | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||||||||||
| Cough | 5/156 (3.2%) | 5/154 (3.2%) | 8/154 (5.2%) | 1/76 (1.3%) | 0/25 (0%) | 0/14 (0%) | 5/129 (3.9%) | 10/230 (4.3%) | 18/405 (4.4%) | 2/56 (3.6%) | 8/96 (8.3%) | 4/93 (4.3%) | 36/469 (7.7%) | 0/7 (0%) | 0/1 (0%) | 2/28 (7.1%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Dyspnoea | 0/156 (0%) | 1/154 (0.6%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 2/230 (0.9%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 7/469 (1.5%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Nasal Congestion | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 1/129 (0.8%) | 2/230 (0.9%) | 3/405 (0.7%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 9/469 (1.9%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Oropharyngeal Pain | 1/156 (0.6%) | 3/154 (1.9%) | 6/154 (3.9%) | 0/76 (0%) | 1/25 (4%) | 0/14 (0%) | 0/129 (0%) | 3/230 (1.3%) | 10/405 (2.5%) | 1/56 (1.8%) | 0/96 (0%) | 4/93 (4.3%) | 19/469 (4.1%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 1/10 (10%) | ||||||||||||||||||
| Upper Respiratory Tract Congestion | 2/156 (1.3%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 1/230 (0.4%) | 1/405 (0.2%) | 0/56 (0%) | 1/96 (1%) | 0/93 (0%) | 3/469 (0.6%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||||||||||||
| Acne | 2/156 (1.3%) | 2/154 (1.3%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 1/14 (7.1%) | 0/129 (0%) | 1/230 (0.4%) | 2/405 (0.5%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 7/469 (1.5%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Alopecia | 3/156 (1.9%) | 0/154 (0%) | 4/154 (2.6%) | 1/76 (1.3%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 2/230 (0.9%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 2/93 (2.2%) | 4/469 (0.9%) | 0/7 (0%) | 0/1 (0%) | 2/28 (7.1%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Blister | 1/156 (0.6%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Dermal Cyst | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Dermatitis Allergic | 4/156 (2.6%) | 1/154 (0.6%) | 1/154 (0.6%) | 0/76 (0%) | 1/25 (4%) | 1/14 (7.1%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 1/93 (1.1%) | 4/469 (0.9%) | 0/7 (0%) | 0/1 (0%) | 3/28 (10.7%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Drug Eruption | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 1/56 (1.8%) | 0/96 (0%) | 0/93 (0%) | 1/469 (0.2%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Eczema | 3/156 (1.9%) | 1/154 (0.6%) | 1/154 (0.6%) | 1/76 (1.3%) | 0/25 (0%) | 1/14 (7.1%) | 2/129 (1.6%) | 2/230 (0.9%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 7/469 (1.5%) | 1/7 (14.3%) | 0/1 (0%) | 3/28 (10.7%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
| Rash | 3/156 (1.9%) | 9/154 (5.8%) | 6/154 (3.9%) | 1/76 (1.3%) | 0/25 (0%) | 1/14 (7.1%) | 2/129 (1.6%) | 7/230 (3%) | 11/405 (2.7%) | 2/56 (3.6%) | 1/96 (1%) | 3/93 (3.2%) | 16/469 (3.4%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/10 (0%) | ||||||||||||||||||
| Rash Erythematous | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Vascular disorders | ||||||||||||||||||||||||||||||||||||
| Hot Flush | 1/156 (0.6%) | 1/154 (0.6%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 0/405 (0%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 0/469 (0%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Hypertension | 4/156 (2.6%) | 1/154 (0.6%) | 1/154 (0.6%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 1/129 (0.8%) | 5/230 (2.2%) | 11/405 (2.7%) | 2/56 (3.6%) | 0/96 (0%) | 3/93 (3.2%) | 12/469 (2.6%) | 0/7 (0%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 1/10 (10%) | ||||||||||||||||||
| Phlebitis | 0/156 (0%) | 0/154 (0%) | 0/154 (0%) | 0/76 (0%) | 0/25 (0%) | 0/14 (0%) | 0/129 (0%) | 0/230 (0%) | 1/405 (0.2%) | 0/56 (0%) | 0/96 (0%) | 0/93 (0%) | 2/469 (0.4%) | 1/7 (14.3%) | 0/1 (0%) | 0/28 (0%) | 0/19 (0%) | 0/10 (0%) | ||||||||||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
12 months after study ends, sponsor will be provided with a copy of the materials at least 45 days prior to submission, with details of proposed date, journal or conference name of publication & it will have 30 days post receipt to send a written request that the publication be delayed on the basis it exposes intellectual property that requires propriety protection but it will be only for 60 days after which investigator will be free to publish. The participation of sponsor will be acknowledged.
Results Point of Contact
| Name/Title | Senior Director |
|---|---|
| Organization | Janssen Research & Development |
| Phone | 215-793-7540 |
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00488631
Other Study ID Numbers:
- CR014179
- 2006-003399-37
- C0524T18
First Posted:
Jun 20, 2007
Last Update Posted:
Apr 26, 2016
Last Verified:
Mar 1, 2016