An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00726388
• Collaborator: (none)
• Enrollment: 1,050
• Locations: 46
• Arm: 1
• Actual Duration (Months): 7.7
• Patients Per Site: 22.8
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: DIC075V (intravenous diclofenac sodium)	Phase 3

Detailed Description

This is an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of DIC075V in patients with acute post-operative pain following abdominal (i.e., non-laparoscopic abdominal surgeries) or orthopedic (e.g., hip or knee joint replacement) surgery. Eligible patients will receive DIC075V IV bolus q6 hours. Safety assessments will be collected at baseline (immediately prior to starting DIC075V therapy) and at study discharge or early termination.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1050 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Multiple-Dose, Multiple-Day, Non-Randomized, Single-Arm Safety Study Of Repeat-Doses Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
• Actual Study Start Date: Sep 15, 2008
• Actual Primary Completion Date: May 8, 2009
• Actual Study Completion Date: May 8, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days	Drug: DIC075V (intravenous diclofenac sodium); multiple doses up to 5 days

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)]

   An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included SAEs and all non-SAEs that occurred during the study.

2. Number of Participants Who Took at Least 1 Concomitant Medication [Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)]

   Concomitant medications were medications that were taken concurrently on or after first dose of study drug.

3. Number of Participants With Abnormal Urinalysis Findings [Baseline (Day 1, immediately before dosing) up to study discharge/early termination (maximum up to Day 5)]

   Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator.

4. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline [Baseline (Day 1, immediately before dosing)]

   12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.

5. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination [Study discharge/early termination (maximum up to Day 5)]

   12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.

6. Change From Baseline in Blood Pressure at Study Discharge/Early Termination [Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)]

   Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) in millimeter of mercury (mmHg) was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.

7. Change From Baseline in Blood Pressure at Clinic Follow-up Visit [Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)]

   Change from baseline in SBP and DBP in mmHg was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.

8. Change From Baseline in Respiratory Rate at Study Discharge/Early Termination [Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)]

   Respiratory rate was measured after the participant had taken rest for 5 minutes.

9. Change From Baseline in Respiratory Rate at Clinic Follow-up Visit [Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)]

   Respiratory rate was measured after the participant had taken rest for 5 minutes.

10. Change From Baseline in Heart Rate at Study Discharge/Early Termination [Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)]

    Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.

11. Change From Baseline in Heart Rate at Clinic Follow-up Visit [Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)]

    Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.

12. Number of Participants With Wound Assessment at Study Discharge/Early Termination [Study discharge/early termination (maximum up to Day 5)]

    Wound assessment had 6 questions, completed by investigator/sub-investigator. Question related to extent of healing; extent and degree of inflammation and extent of drainage had options: much better than expected, better than expected, normal, slower than expected, and much slower than expected. Question related to separation of surgical incision had options: no separation, barely detectible separation, localized separation, mostly separated, and complete separation (dehiscence). Question related to infection at surgical site had options: definitely, no infection, possibly infected, probably infected, certainly infected, and abscess/gross cellulitis. Question related to prescription of postoperative systemic antibiotics had options: no, yes for prophylaxis, and yes for infection. Every question there was category "Not Done" for participants with no wound assessment other than the reason 'missing' and category "Missing", where participants were missing for wound assessment.

13. Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline [Baseline (Day 1, immediately before dosing)]

    Thrombophlebitis assessment evaluation was done using following grades: 0 equals to (=) no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.

14. Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination [Study discharge/early termination (maximum up to Day 5)]

    Thrombophlebitis assessment evaluation was done using following grades: 0= no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.

15. Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening [Screening (0 to 21 days prior to surgery)]

    Physical examination included the assessment of general appearance, skin; head, ears, eyes, nose, and throat (HEENT); neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.

16. Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit [Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)]

    Physical examination included the assessment of general appearance, skin; HEENT; neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• abdominal ( non-laparoscopic abdominal surgeries) or orthopedic ( hip or knee joint replacement) surgery or other surgeries requiring multiple doses of parenterally administered NSAIDs over multiple days

• Expected stay > 48 hrs

Exclusion Criteria:

• bilirubin > 2.5 mg/dl

• prothrombin time is > 20% above the upper limit of normal

• serum creatinine is > 1.9 mg/dl at screening.

• known allergy or hypersensitivity to diclofenac, other NSAIDs,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Alabama Research, LLC	Birmingham	Alabama	United States	35209
2	Alabama Clinical Therapeutics	Birmingham	Alabama	United States	35235
3	Shoals Clinical Research Associates, LLC, Eliza Coffee Memorial Hospital	Florence	Alabama	United States	35630
4	Horizon Research Group	Mobile	Alabama	United States	36608
5	Drug Research and Analysis Corp.	Montgomery	Alabama	United States	36106
6	Jackson Hospital	Montgomery	Alabama	United States	36106
7	Helen Keller Memorial Hospital	Sheffield	Alabama	United States	35660
8	Pivotal Clinical Research	Peoria	Arizona	United States	85381
9	Precision Trials	Phoenix	Arizona	United States	85032
10	Teton Research, LLC	Little Rock	Arkansas	United States	72205
11	Vertex	Bakersfield	California	United States	93311
12	Lotus Clinical Research	Glendale	California	United States	91206
13	Physicians Clinical Research	Laguna Hills	California	United States	92653
14	National Institute of Clinical Research	Los Angeles	California	United States	90017
15	Lotus Clinical Research	Pasadena	California	United States	91105
16	Santa Barbara Cottage Hospital	Santa Barbara	California	United States	93105
17	North Coast Women's Care	Vista	California	United States	92083
18	American Clinical Research	Aurora	Colorado	United States
19	Colorado Orthopedic Consultants	Englewood	Colorado	United States	80110
20	American Clinical Research Services	Steamboat Springs	Colorado	United States	80487
21	Orthopedic Associates of Hartford	Hartford	Connecticut	United States	06106
22	Nature Coast Clinical Research	Inverness	Florida	United States	34452
23	Sunrise Medical Research, Inc.	Lauderdale Lakes	Florida	United States
24	Pensacola Research Consultants	Pensacola	Florida	United States	32504
25	Florida Orthopedic Institute	Tampa	Florida	United States	33637
26	Soapstone Center for Clinical Research	Decatur	Georgia	United States	33034
27	JRSI Foundation The center for Hip and Knee Surgery	Mooresville	Indiana	United States	46158
28	University of Kansas Medical Center Department of Anesthesiology	Kansas City	Kansas	United States	66160
29	Validity Research	Merriam	Kansas	United States	66204
30	Tulane Univ. Medical Center	New Orleans	Louisiana	United States	70113
31	Great Falls Clinic, LLP	Great Falls	Montana	United States	59405
32	Albany Medical Center	Albany	New York	United States	12208
33	Staten Island University Hospital	Staten Island	New York	United States	10305
34	The Ohio State University Medical Center	Columbus	Ohio	United States	43210
35	Allegheny Pain Management	Altoona	Pennsylvania	United States	16602
36	University of Orthopedics Center	Altoona	Pennsylvania	United States	16602
37	Ilumina Clinical Associates	Johnstown	Pennsylvania	United States	15504
38	Ilumina Clinical Associates	Johnstown	Pennsylvania	United States	15904
39	UPMC Presbyterian-Shadyshide Hospital	Pittsburgh	Pennsylvania	United States	15232
40	UPMC-St. Margaret's Hospital	Pittsburgh	Pennsylvania	United States	15232
41	Somerset Hospital	Somerset	Pennsylvania	United States	15501
42	University Orthopedics Center	State College	Pennsylvania	United States	16801
43	Comprehensive Pain Specialists, PLLC	Hendersonville	Tennessee	United States	37075
44	Endeavor Clinical Trials	San Antonio	Texas	United States	78229
45	Interventional Pain Management	San Antonio	Texas	United States	78258
46	Scott & White Clinic / Texas A&M Health Science Center	Temple	Texas	United States	76508

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00726388
• Other Study ID Numbers: DFC-010; C1211011
• First Posted: Jul 31, 2008
• Last Update Posted: Oct 13, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Keywords provided by Pfizer: safety; diclofenac; pain, postoperative
• Additional relevant MeSH terms: Pain, Postoperative; Diclofenac

Study Results

Participant Flow

Recruitment Details	Participants with immediate acute postoperative pain, who were stable according to the study site's usual practice, were enrolled in the study. They received intravenous (IV) diclofenac sodium (DIC075V) bolus as their primary postoperative analgesic.
Pre-assignment Detail	Total 1171 participants signed the inform consent form (ICF). Out of which 121 participants were screen failure and 1050 actually enrolled into the study and 971 assigned to study treatment.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing greater than or equal to (>=) 95 kg received DIC075V 50 milligram (mg) IV bolus once every 6 hours. Participants with more than 1 non-steroidal anti-inflammatory drug (NSAIDS) related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Period Title: Overall Study
STARTED	1050
Treated	971
COMPLETED	943
NOT COMPLETED	107

Baseline Characteristics

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Overall Participants	971
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.8 (13.4)
Sex: Female, Male (Count of Participants)
Female	617 63.5%
Male	354 36.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included SAEs and all non-SAEs that occurred during the study.
Time Frame	Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	971
TEAEs	823 84.8%
SAEs	73 7.5%

2. Primary Outcome

Title	Number of Participants Who Took at Least 1 Concomitant Medication
Description	Concomitant medications were medications that were taken concurrently on or after first dose of study drug.
Time Frame	Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	971
Count of Participants [Participants]	971 100%

3. Primary Outcome

Title	Number of Participants With Abnormal Urinalysis Findings
Description	Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator.
Time Frame	Baseline (Day 1, immediately before dosing) up to study discharge/early termination (maximum up to Day 5)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	971
Count of Participants [Participants]	2 0.2%

4. Primary Outcome

Title	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline
Description	12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Time Frame	Baseline (Day 1, immediately before dosing)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	971
Count of Participants [Participants]	14 1.4%

5. Primary Outcome

Title	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination
Description	12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Time Frame	Study discharge/early termination (maximum up to Day 5)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	971
Count of Participants [Participants]	13 1.3%

6. Primary Outcome

Title	Change From Baseline in Blood Pressure at Study Discharge/Early Termination
Description	Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) in millimeter of mercury (mmHg) was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.
Time Frame	Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	958
SBP	-2.2 (21.5)
DBP	-0.5 (14.7)

7. Primary Outcome

Title	Change From Baseline in Blood Pressure at Clinic Follow-up Visit
Description	Change from baseline in SBP and DBP in mmHg was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.
Time Frame	Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	941
SBP	0.2 (21.4)
DBP	4.4 (13.9)

8. Primary Outcome

Title	Change From Baseline in Respiratory Rate at Study Discharge/Early Termination
Description	Respiratory rate was measured after the participant had taken rest for 5 minutes.
Time Frame	Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	957
Mean (Standard Deviation) [Breaths per minute]	1.3 (3.0)

9. Primary Outcome

Title	Change From Baseline in Respiratory Rate at Clinic Follow-up Visit
Description	Respiratory rate was measured after the participant had taken rest for 5 minutes.
Time Frame	Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	937
Mean (Standard Deviation) [Breaths per minute]	1.0 (3.8)

10. Primary Outcome

Title	Change From Baseline in Heart Rate at Study Discharge/Early Termination
Description	Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.
Time Frame	Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	958
Mean (Standard Deviation) [Beats per minute]	3.8 (15.4)

11. Primary Outcome

Title	Change From Baseline in Heart Rate at Clinic Follow-up Visit
Description	Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.
Time Frame	Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	939
Mean (Standard Deviation) [Beats per minute]	2.4 (15.5)

12. Primary Outcome

Title	Number of Participants With Wound Assessment at Study Discharge/Early Termination
Description	Wound assessment had 6 questions, completed by investigator/sub-investigator. Question related to extent of healing; extent and degree of inflammation and extent of drainage had options: much better than expected, better than expected, normal, slower than expected, and much slower than expected. Question related to separation of surgical incision had options: no separation, barely detectible separation, localized separation, mostly separated, and complete separation (dehiscence). Question related to infection at surgical site had options: definitely, no infection, possibly infected, probably infected, certainly infected, and abscess/gross cellulitis. Question related to prescription of postoperative systemic antibiotics had options: no, yes for prophylaxis, and yes for infection. Every question there was category "Not Done" for participants with no wound assessment other than the reason 'missing' and category "Missing", where participants were missing for wound assessment.
Time Frame	Study discharge/early termination (maximum up to Day 5)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	971
Extent of healing: Much better than expected	40 4.1%
Extent of healing: Better than expected	154 15.9%
Extent of healing: Normal	727 74.9%
Extent of healing: Slower than expected	11 1.1%
Extent of healing: Much slower than expected	0 0%
Extent of healing: Not done	33 3.4%
Extent of healing: Missing	6 0.6%
Extent and degree of Inflammation: Much better than expected	50 5.1%
Extent and degree of inflammation: Better than expected	214 22%
Extent and degree of Inflammation: Normal	657 67.7%
Extent and degree of Inflammation: Slower than expected	11 1.1%
Extent and degree of Inflammation: Much slower than expected	0 0%
Extent and degree of inflammation: Not done	33 3.4%
Extent and degree of inflammation: Missing	6 0.6%
Extent of drainage: Much better than expected	78 8%
Extent of drainage: Better than expected	195 20.1%
Extent of drainage: Normal	633 65.2%
Extent of drainage: Slower than expected	29 3%
Extent of drainage: Much slower than expected	1 0.1%
Extent of drainage: Not done	33 3.4%
Extent of drainage: Missing	2 0.2%
Separation of Incision: No separation	809 83.3%
Separation of Incision: Barely detectable separation	87 9%
Separation of incision: Localized separation	35 3.6%
Separation of incision: Mostly separated	0 0%
Separation of incision: Complete separation	0 0%
Separation of incision: Not done	33 3.4%
Separation of incision: Missing	7 0.7%
Infection at surgical site: Definitely, No infection	921 94.9%
Infection at surgical site: Possibly infected	12 1.2%
Infection at surgical site: Probably infected	1 0.1%
Infection at surgical site: Certainly infected	1 0.1%
Infection at surgical site: Abscess or gross cellulitis	0 0%
Infection at surgical site: Not done	33 3.4%
Infection at surgical site: Missing	3 0.3%
Postoperative systemic antibiotics: No	673 69.3%
Postoperative systemic antibiotics: Yes, for prophylaxis	262 27%
Postoperative systemic antibiotics: Yes, for infection	1 0.1%
Postoperative systemic antibiotics: Not done	33 3.4%
Postoperative systemic antibiotics: Missing	2 0.2%

13. Primary Outcome

Title	Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline
Description	Thrombophlebitis assessment evaluation was done using following grades: 0 equals to (=) no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.
Time Frame	Baseline (Day 1, immediately before dosing)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	963
Grade 0	960 98.9%
Grade 1	3 0.3%
Grade 2	0 0%
Grade 3	0 0%
Grade 4	0 0%
Grade 5	0 0%

14. Primary Outcome

Title	Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination
Description	Thrombophlebitis assessment evaluation was done using following grades: 0= no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.
Time Frame	Study discharge/early termination (maximum up to Day 5)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	957
Grade 0	925 95.3%
Grade 1	26 2.7%
Grade 2	3 0.3%
Grade 3	3 0.3%
Grade 4	0 0%
Grade 5	0 0%

15. Primary Outcome

Title	Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening
Description	Physical examination included the assessment of general appearance, skin; head, ears, eyes, nose, and throat (HEENT); neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.
Time Frame	Screening (0 to 21 days prior to surgery)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who had received DIC075V and had at least 1 safety assessment.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	971
General Appearance	8 0.8%
Skin	3 0.3%
HEENT	7 0.7%
Neck/Thyroid	1 0.1%
Oral Cavity	2 0.2%
Lymph Nodes	0 0%
Cardiovascular	3 0.3%
Lungs	0 0%
Breasts	0 0%
Abdomen	29 3%
Genitourinary	32 3.3%
Neurologic	10 1%
Joints/Extremities	295 30.4%

16. Primary Outcome

Title	Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit
Description	Physical examination included the assessment of general appearance, skin; HEENT; neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.
Time Frame	Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who had received DIC075V and had at least 1 safety assessment.

Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
Measure Participants	971
General appearance	8 0.8%
Skin	13 1.3%
HEENT	2 0.2%
Neck/Thyroid	1 0.1%
Oral Cavity	0 0%
Lymph Nodes	0 0%
Cardiovascular	5 0.5%
Lungs	5 0.5%
Breasts	0 0%
Abdomen	12 1.2%
Genitourinary	1 0.1%
Neurologic	5 0.5%
Joints/Extremities	41 4.2%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Arm/Group Title	DIC075V
Arm/Group Description	Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
All Cause Mortality
	DIC075V
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	DIC075V
	Affected / at Risk (%)	# Events
Total	73/971 (7.5%)
Cardiac disorders
ATRIAL FIBRILLATION	2/971 (0.2%)
CARDIAC FAILURE CONGESTIVE	1/971 (0.1%)
CARDIO-RESPIRATORY ARREST	1/971 (0.1%)
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION	3/971 (0.3%)
NAUSEA	2/971 (0.2%)
VOMITING	2/971 (0.2%)
ABDOMINAL PAIN	1/971 (0.1%)
ANAL HAEMORRHAGE	1/971 (0.1%)
CONSTIPATION	1/971 (0.1%)
ENTEROCUTANEOUS FISTULA	1/971 (0.1%)
HAEMATOCHEZIA	1/971 (0.1%)
INTESTINAL PERFORATION	1/971 (0.1%)
PANCREATITIS	1/971 (0.1%)
PERITONITIS	1/971 (0.1%)
UPPER GASTROINTESTINAL HAEMORRHAGE	1/971 (0.1%)
General disorders
PYREXIA	2/971 (0.2%)
NON-CARDIAC CHEST PAIN	1/971 (0.1%)
OEDEMA PERIPHERAL	1/971 (0.1%)
Infections and infestations
INCISION SITE CELLULITIS	3/971 (0.3%)
WOUND INFECTION	3/971 (0.3%)
CELLULITIS	2/971 (0.2%)
POSTOPERATIVE WOUND INFECTION	2/971 (0.2%)
SEPSIS	2/971 (0.2%)
ABDOMINAL WALL ABSCESS	1/971 (0.1%)
BRONCHITIS	1/971 (0.1%)
CATHETER SEPSIS	1/971 (0.1%)
HAEMATOMA INFECTION	1/971 (0.1%)
INCISION SITE ABSCESS	1/971 (0.1%)
INCISION SITE INFECTION	1/971 (0.1%)
LOBAR PNEUMONIA	1/971 (0.1%)
PELVIC ABSCESS	1/971 (0.1%)
POST PROCEDURAL CELLULITIS	1/971 (0.1%)
VAGINAL CELLULITIS	1/971 (0.1%)
WOUND ABSCESS	1/971 (0.1%)
WOUND INFECTION STAPHYLOCOCCAL	1/971 (0.1%)
BACTERAEMIA	1/971 (0.1%)
Injury, poisoning and procedural complications
FEMUR FRACTURE	5/971 (0.5%)
WOUND DEHISCENCE	2/971 (0.2%)
ANASTOMOTIC HAEMORRHAGE	1/971 (0.1%)
ANASTOMOTIC LEAK	1/971 (0.1%)
CONTUSION	1/971 (0.1%)
INCISION SITE HAEMATOMA	1/971 (0.1%)
INCISION SITE PAIN	1/971 (0.1%)
POST PROCEDURAL DISCHARGE	1/971 (0.1%)
POST PROCEDURAL HAEMORRHAGE	1/971 (0.1%)
POSTOPERATIVE ILEUS	1/971 (0.1%)
POSTOPERATIVE WOUND COMPLICATION	1/971 (0.1%)
TENDON RUPTURE	1/971 (0.1%)
Investigations
BLOOD CREATININE INCREASED	3/971 (0.3%)
BLOOD CREATINE PHOSPHOKINASE INCREASED	2/971 (0.2%)
BLOOD CULTURE POSITIVE	1/971 (0.1%)
ELECTROCARDIOGRAM QT PROLONGED	1/971 (0.1%)
LIVER FUNCTION TEST ABNORMAL	1/971 (0.1%)
Metabolism and nutrition disorders
DEHYDRATION	1/971 (0.1%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	1/971 (0.1%)
PAIN IN EXTREMITY	1/971 (0.1%)
RHABDOMYOLYSIS	1/971 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN SMALL INTESTINAL NEOPLASM	1/971 (0.1%)
Nervous system disorders
SEDATION	2/971 (0.2%)
Psychiatric disorders
MENTAL STATUS CHANGES	1/971 (0.1%)
Renal and urinary disorders
RENAL FAILURE ACUTE	2/971 (0.2%)
RENAL FAILURE	1/971 (0.1%)
RENAL TUBULAR NECROSIS	1/971 (0.1%)
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM	6/971 (0.6%)
HYPOXIA	2/971 (0.2%)
ACUTE RESPIRATORY DISTRESS SYNDROME	1/971 (0.1%)
ASPIRATION	1/971 (0.1%)
ATELECTASIS	1/971 (0.1%)
DYSPNOEA	1/971 (0.1%)
PLEURAL EFFUSION	1/971 (0.1%)
PULMONARY OEDEMA	1/971 (0.1%)
RESPIRATORY ARREST	1/971 (0.1%)
Skin and subcutaneous tissue disorders
ANGIOEDEMA	1/971 (0.1%)
Vascular disorders
HYPOTENSION	1/971 (0.1%)
Other (Not Including Serious) Adverse Events
	DIC075V
	Affected / at Risk (%)	# Events
Total	816/971 (84%)
Blood and lymphatic system disorders
ANAEMIA	8/971 (0.8%)
THROMBOCYTOPENIA	11/971 (1.1%)
LEUKOCYTOSIS	11/971 (1.1%)
HAEMORRHAGIC ANAEMIA	3/971 (0.3%)
COAGULOPATHY	2/971 (0.2%)
THROMBOCYTHAEMIA	1/971 (0.1%)
Cardiac disorders
BRADYCARDIA	10/971 (1%)
ATRIAL FIBRILLATION	6/971 (0.6%)
TACHYCARDIA	32/971 (3.3%)
SINUS TACHYCARDIA	4/971 (0.4%)
SINUS BRADYCARDIA	3/971 (0.3%)
ANGINA PECTORIS	2/971 (0.2%)
ARRHYTHMIA	2/971 (0.2%)
CARDIAC FAILURE CONGESTIVE	1/971 (0.1%)
CARDIOMEGALY	2/971 (0.2%)
MYOCARDIAL INFARCTION	2/971 (0.2%)
SUPRAVENTRICULAR EXTRASYSTOLES	2/971 (0.2%)
ARTERIOSCLEROSIS CORONARY ARTERY	1/971 (0.1%)
BUNDLE BRANCH BLOCK LEFT	1/971 (0.1%)
BUNDLE BRANCH BLOCK RIGHT	1/971 (0.1%)
MYOCARDIAL ISCHAEMIA	1/971 (0.1%)
PALPITATIONS	1/971 (0.1%)
PERICARDIAL EFFUSION	1/971 (0.1%)
RIGHT VENTRICULAR HYPERTROPHY	1/971 (0.1%)
Ear and labyrinth disorders
TINNITUS	1/971 (0.1%)
Endocrine disorders
GOITRE	1/971 (0.1%)
Eye disorders
CONJUNCTIVITIS	1/971 (0.1%)
DRY EYE	1/971 (0.1%)
EYE IRRITATION	1/971 (0.1%)
EYE PAIN	1/971 (0.1%)
EYELID DISORDER	1/971 (0.1%)
VISION BLURRED	1/971 (0.1%)
Gastrointestinal disorders
NAUSEA	359/971 (37%)
CONSTIPATION	181/971 (18.6%)
VOMITING	81/971 (8.3%)
FLATULENCE	38/971 (3.9%)
DYSPEPSIA	36/971 (3.7%)
DIARRHOEA	28/971 (2.9%)
ABDOMINAL DISTENSION	16/971 (1.6%)
DRY MOUTH	11/971 (1.1%)
ABDOMINAL PAIN	7/971 (0.7%)
GASTROOESOPHAGEAL REFLUX DISEASE	5/971 (0.5%)
ABDOMINAL DISCOMFORT	3/971 (0.3%)
HAEMATOCHEZIA	2/971 (0.2%)
STOMACH DISCOMFORT	3/971 (0.3%)
GASTRITIS	2/971 (0.2%)
HAEMORRHOIDS	2/971 (0.2%)
LIP DRY	2/971 (0.2%)
RETCHING	2/971 (0.2%)
ABDOMINAL PAIN UPPER	1/971 (0.1%)
ABDOMINAL TENDERNESS	1/971 (0.1%)
ANAL ULCER	1/971 (0.1%)
ASCITES	1/971 (0.1%)
COLONIC POLYP	1/971 (0.1%)
EPIGASTRIC DISCOMFORT	1/971 (0.1%)
ERUCTATION	1/971 (0.1%)
GASTROINTESTINAL PAIN	1/971 (0.1%)
HAEMATEMESIS	1/971 (0.1%)
ILEUS	1/971 (0.1%)
ILEUS PARALYTIC	1/971 (0.1%)
LIP ULCERATION	1/971 (0.1%)
PARAESTHESIA ORAL	1/971 (0.1%)
RECTAL DISCHARGE	1/971 (0.1%)
SWOLLEN TONGUE	1/971 (0.1%)
RECTAL HAEMORRHAGE	1/971 (0.1%)
TONGUE BLISTERING	1/971 (0.1%)
TONGUE DISORDER	1/971 (0.1%)
TOOTHACHE	1/971 (0.1%)
General disorders
PYREXIA	56/971 (5.8%)
INFUSION SITE PAIN	50/971 (5.1%)
OEDEMA PERIPHERAL	37/971 (3.8%)
ASTHENIA	25/971 (2.6%)
INFUSION SITE EXTRAVASATION	14/971 (1.4%)
CHILLS	12/971 (1.2%)
HYPOTHERMIA	12/971 (1.2%)
INFUSION SITE THROMBOSIS	6/971 (0.6%)
FATIGUE	4/971 (0.4%)
GENERALISED OEDEMA	4/971 (0.4%)
INFUSION SITE ERYTHEMA	4/971 (0.4%)
INFUSION SITE SWELLING	4/971 (0.4%)
BREAKTHROUGH PAIN	3/971 (0.3%)
CHEST PAIN	3/971 (0.3%)
INFUSION SITE OEDEMA	3/971 (0.3%)
CHEST DISCOMFORT	2/971 (0.2%)
INFUSION SITE IRRITATION	2/971 (0.2%)
OEDEMA	2/971 (0.2%)
ADVERSE DRUG REACTION	1/971 (0.1%)
APPLICATION SITE VESICLES	1/971 (0.1%)
EARLY SATIETY	1/971 (0.1%)
FACE OEDEMA	1/971 (0.1%)
FEELING HOT	1/971 (0.1%)
IMPAIRED HEALING	1/971 (0.1%)
INFUSION SITE BRUISING	1/971 (0.1%)
INFUSION SITE HAEMATOMA	1/971 (0.1%)
INFUSION SITE HAEMORRHAGE	1/971 (0.1%)
INFUSION SITE PARAESTHESIA	1/971 (0.1%)
INFUSION SITE WARMTH	1/971 (0.1%)
INJECTION SITE HAEMORRHAGE	1/971 (0.1%)
INJECTION SITE PAIN	1/971 (0.1%)
INJECTION SITE SWELLING	1/971 (0.1%)
PAIN	1/971 (0.1%)
PITTING OEDEMA	1/971 (0.1%)
THIRST	1/971 (0.1%)
Hepatobiliary disorders
CHOLELITHIASIS	1/971 (0.1%)
Infections and infestations
URINARY TRACT INFECTION	20/971 (2.1%)
WOUND INFECTION	9/971 (0.9%)
POSTOPERATIVE WOUND INFECTION	4/971 (0.4%)
CELLULITIS	3/971 (0.3%)
INCISION SITE INFECTION	4/971 (0.4%)
NASOPHARYNGITIS	5/971 (0.5%)
INCISION SITE ABSCESS	3/971 (0.3%)
PNEUMONIA	4/971 (0.4%)
SINUSITIS	4/971 (0.4%)
UPPER RESPIRATORY TRACT INFECTION	4/971 (0.4%)
BRONCHITIS	2/971 (0.2%)
STAPHYLOCOCCAL INFECTION	3/971 (0.3%)
BACTERAEMIA	1/971 (0.1%)
CANDIDIASIS	2/971 (0.2%)
CLOSTRIDIUM DIFFICILE COLITIS	2/971 (0.2%)
FUNGAL INFECTION	2/971 (0.2%)
GASTROENTERITIS VIRAL	2/971 (0.2%)
WOUND INFECTION STAPHYLOCOCCAL	1/971 (0.1%)
ANAL TINEA	1/971 (0.1%)
CYSTITIS	1/971 (0.1%)
FOLLICULITIS	1/971 (0.1%)
GASTROENTERITIS	1/971 (0.1%)
INFECTION	1/971 (0.1%)
KIDNEY INFECTION	1/971 (0.1%)
ORAL HERPES	1/971 (0.1%)
OSTEOMYELITIS ACUTE	1/971 (0.1%)
PHARYNGITIS STREPTOCOCCAL	1/971 (0.1%)
RESPIRATORY TRACT INFECTION	1/971 (0.1%)
TINEA PEDIS	1/971 (0.1%)
TOOTH ABSCESS	1/971 (0.1%)
VAGINAL INFECTION	1/971 (0.1%)
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE	218/971 (22.5%)
INCISION SITE COMPLICATION	13/971 (1.3%)
POST PROCEDURAL OEDEMA	12/971 (1.2%)
INCISION SITE ERYTHEMA	9/971 (0.9%)
POST PROCEDURAL DISCHARGE	8/971 (0.8%)
WOUND DEHISCENCE	6/971 (0.6%)
INCISION SITE HAEMORRHAGE	7/971 (0.7%)
CONTUSION	5/971 (0.5%)
FALL	6/971 (0.6%)
FEMUR FRACTURE	1/971 (0.1%)
POST PROCEDURAL HAEMORRHAGE	3/971 (0.3%)
INCISION SITE OEDEMA	3/971 (0.3%)
PROCEDURAL HYPOTENSION	3/971 (0.3%)
SEROMA	3/971 (0.3%)
SKIN LACERATION	3/971 (0.3%)
EXCORIATION	2/971 (0.2%)
INCISION SITE PAIN	1/971 (0.1%)
POSTOPERATIVE WOUND COMPLICATION	1/971 (0.1%)
PROCEDURAL NAUSEA	2/971 (0.2%)
ESCHAR	1/971 (0.1%)
FRACTURE	1/971 (0.1%)
HIP FRACTURE	1/971 (0.1%)
INCISION SITE BLISTER	1/971 (0.1%)
JOINT DISLOCATION	1/971 (0.1%)
LIGAMENT RUPTURE	1/971 (0.1%)
PROCEDURAL HYPERTENSION	1/971 (0.1%)
PROCEDURAL SITE REACTION	1/971 (0.1%)
PROCEDURAL VOMITING	1/971 (0.1%)
THERMAL BURN	1/971 (0.1%)
WOUND COMPLICATION	1/971 (0.1%)
WOUND SECRETION	1/971 (0.1%)
INCISION SITE HAEMATOMA	1/971 (0.1%)
DEPRESSION POSTOPERATIVE	1/971 (0.1%)
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED	61/971 (6.3%)
PROTHROMBIN TIME PROLONGED	14/971 (1.4%)
BLOOD CREATININE INCREASED	7/971 (0.7%)
URINE OUTPUT DECREASED	10/971 (1%)
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	8/971 (0.8%)
BREATH SOUNDS ABNORMAL	8/971 (0.8%)
OXYGEN SATURATION DECREASED	7/971 (0.7%)
BODY TEMPERATURE INCREASED	6/971 (0.6%)
LIVER FUNCTION TEST ABNORMAL	5/971 (0.5%)
ALANINE AMINOTRANSFERASE INCREASED	5/971 (0.5%)
BLOOD AMYLASE INCREASED	5/971 (0.5%)
BLOOD GLUCOSE INCREASED	5/971 (0.5%)
ASPARTATE AMINOTRANSFERASE INCREASED	4/971 (0.4%)
LIPASE INCREASED	4/971 (0.4%)
BLOOD BILIRUBIN INCREASED	3/971 (0.3%)
BLOOD MAGNESIUM DECREASED	3/971 (0.3%)
GAMMA-GLUTAMYLTRANSFERASE INCREASED	3/971 (0.3%)
INTERNATIONAL NORMALISED RATIO INCREASED	3/971 (0.3%)
BLOOD CREATINE PHOSPHOKINASE MB INCREASED	2/971 (0.2%)
BLOOD UREA INCREASED	2/971 (0.2%)
ELECTROCARDIOGRAM QT PROLONGED	1/971 (0.1%)
HEART RATE IRREGULAR	2/971 (0.2%)
PLATELET COUNT DECREASED	2/971 (0.2%)
RESPIRATORY RATE DECREASED	2/971 (0.2%)
RESPIRATORY RATE INCREASED	2/971 (0.2%)
WHITE BLOOD CELL COUNT INCREASED	2/971 (0.2%)
BLOOD ALBUMIN DECREASED	2/971 (0.2%)
BLOOD ALBUMIN INCREASED	1/971 (0.1%)
BLOOD ALKALINE PHOSPHATASE	1/971 (0.1%)
BLOOD ALKALINE PHOSPHATASE DECREASED	1/971 (0.1%)
BLOOD LACTATE DEHYDROGENASE INCREASED	1/971 (0.1%)
BLOOD PRESSURE DECREASED	1/971 (0.1%)
BLOOD PRESSURE INCREASED	1/971 (0.1%)
BLOOD URINE PRESENT	1/971 (0.1%)
CAROTID BRUIT	1/971 (0.1%)
CHEST X-RAY ABNORMAL	1/971 (0.1%)
CREATININE RENAL CLEARANCE DECREASED	1/971 (0.1%)
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL	1/971 (0.1%)
ELECTROCARDIOGRAM T WAVE ABNORMAL	1/971 (0.1%)
FIBRIN D DIMER INCREASED	1/971 (0.1%)
HAEMATOCRIT DECREASED	1/971 (0.1%)
HAEMOGLOBIN DECREASED	1/971 (0.1%)
HEART RATE INCREASED	1/971 (0.1%)
HEPATIC ENZYME INCREASED	1/971 (0.1%)
PROTEIN TOTAL DECREASED	1/971 (0.1%)
PROTEIN TOTAL INCREASED	1/971 (0.1%)
BLOOD ALKALINE PHOSPHATASE INCREASED	1/971 (0.1%)
Metabolism and nutrition disorders
HYPOKALAEMIA	37/971 (3.8%)
HYPERGLYCAEMIA	13/971 (1.3%)
HYPONATRAEMIA	13/971 (1.3%)
HYPOCALCAEMIA	9/971 (0.9%)
HYPERKALAEMIA	5/971 (0.5%)
HYPOMAGNESAEMIA	5/971 (0.5%)
DEHYDRATION	3/971 (0.3%)
HYPOALBUMINAEMIA	4/971 (0.4%)
HYPOGLYCAEMIA	4/971 (0.4%)
HYPOPROTEINAEMIA	4/971 (0.4%)
ANOREXIA	3/971 (0.3%)
DECREASED APPETITE	3/971 (0.3%)
DIABETES MELLITUS	3/971 (0.3%)
HYPERPHOSPHATAEMIA	2/971 (0.2%)
HYPOCHLORAEMIA	2/971 (0.2%)
FLUID RETENTION	1/971 (0.1%)
GOUT	1/971 (0.1%)
HYPERCALCAEMIA	1/971 (0.1%)
HYPERCHOLESTEROLAEMIA	1/971 (0.1%)
HYPERMAGNESAEMIA	1/971 (0.1%)
HYPOVOLAEMIA	1/971 (0.1%)
IMPAIRED FASTING GLUCOSE	1/971 (0.1%)
KWASHIORKOR	1/971 (0.1%)
METABOLIC ACIDOSIS	1/971 (0.1%)
TYPE 2 DIABETES MELLITUS	1/971 (0.1%)
VITAMIN B12 DEFICIENCY	1/971 (0.1%)
VITAMIN D DEFICIENCY	1/971 (0.1%)
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS	34/971 (3.5%)
PAIN IN EXTREMITY	16/971 (1.6%)
ARTHRALGIA	6/971 (0.6%)
BACK PAIN	7/971 (0.7%)
MUSCULOSKELETAL PAIN	7/971 (0.7%)
JOINT SWELLING	6/971 (0.6%)
MUSCLE TIGHTNESS	3/971 (0.3%)
NECK PAIN	3/971 (0.3%)
ARTHRITIS	2/971 (0.2%)
MUSCULAR WEAKNESS	2/971 (0.2%)
ARTHROFIBROSIS	1/971 (0.1%)
COSTOCHONDRITIS	1/971 (0.1%)
EXOSTOSIS	1/971 (0.1%)
GROIN PAIN	1/971 (0.1%)
HYPERCREATINAEMIA	1/971 (0.1%)
JOINT EFFUSION	1/971 (0.1%)
JOINT RANGE OF MOTION DECREASED	1/971 (0.1%)
LIMB DISCOMFORT	1/971 (0.1%)
MUSCULOSKELETAL CHEST PAIN	1/971 (0.1%)
MUSCULOSKELETAL DISCOMFORT	1/971 (0.1%)
NECK MASS	1/971 (0.1%)
OSTEOARTHRITIS	1/971 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA	1/971 (0.1%)
THYROID NEOPLASM	1/971 (0.1%)
Nervous system disorders
HEADACHE	56/971 (5.8%)
DIZZINESS	49/971 (5%)
HYPOAESTHESIA	12/971 (1.2%)
SOMNOLENCE	8/971 (0.8%)
PARAESTHESIA	6/971 (0.6%)
PERONEAL NERVE PALSY	4/971 (0.4%)
LETHARGY	3/971 (0.3%)
SEDATION	1/971 (0.1%)
NEUROPATHY PERIPHERAL	2/971 (0.2%)
SINUS HEADACHE	2/971 (0.2%)
SYNCOPE	2/971 (0.2%)
AURA	1/971 (0.1%)
CAROTID ARTERY STENOSIS	1/971 (0.1%)
DYSGEUSIA	1/971 (0.1%)
ENCEPHALOPATHY	1/971 (0.1%)
LOSS OF CONSCIOUSNESS	1/971 (0.1%)
MEMORY IMPAIRMENT	1/971 (0.1%)
MOTOR DYSFUNCTION	1/971 (0.1%)
NERVE COMPRESSION	1/971 (0.1%)
SYNCOPE VASOVAGAL	1/971 (0.1%)
TREMOR	1/971 (0.1%)
Psychiatric disorders
INSOMNIA	130/971 (13.4%)
ANXIETY	22/971 (2.3%)
CONFUSIONAL STATE	9/971 (0.9%)
MENTAL STATUS CHANGES	3/971 (0.3%)
AGITATION	3/971 (0.3%)
DEPRESSION	3/971 (0.3%)
HALLUCINATION	3/971 (0.3%)
RESTLESSNESS	3/971 (0.3%)
ABNORMAL DREAMS	1/971 (0.1%)
DELIRIUM TREMENS	1/971 (0.1%)
DISORIENTATION	1/971 (0.1%)
FLAT AFFECT	1/971 (0.1%)
HALLUCINATION, VISUAL	1/971 (0.1%)
NIGHTMARE	1/971 (0.1%)
Renal and urinary disorders
URINARY RETENTION	21/971 (2.2%)
RENAL FAILURE ACUTE	5/971 (0.5%)
BLADDER SPASM	6/971 (0.6%)
DYSURIA	4/971 (0.4%)
HAEMATURIA	3/971 (0.3%)
RENAL FAILURE	2/971 (0.2%)
INCONTINENCE	2/971 (0.2%)
OLIGURIA	2/971 (0.2%)
URINARY INCONTINENCE	2/971 (0.2%)
ANURIA	1/971 (0.1%)
AZOTAEMIA	1/971 (0.1%)
BLADDER DISCOMFORT	1/971 (0.1%)
BLADDER DISORDER	1/971 (0.1%)
RENAL CYST	1/971 (0.1%)
RENAL DISORDER	1/971 (0.1%)
UROGENITAL FISTULA	1/971 (0.1%)
Reproductive system and breast disorders
TESTICULAR OEDEMA	1/971 (0.1%)
VAGINAL DISCHARGE	1/971 (0.1%)
VAGINAL HAEMORRHAGE	1/971 (0.1%)
VULVOVAGINAL BURNING SENSATION	1/971 (0.1%)
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN	28/971 (2.9%)
DYSPNOEA	15/971 (1.5%)
COUGH	14/971 (1.4%)
NASAL CONGESTION	11/971 (1.1%)
HYPOXIA	4/971 (0.4%)
PLEURAL EFFUSION	6/971 (0.6%)
PULMONARY EMBOLISM	1/971 (0.1%)
ATELECTASIS	5/971 (0.5%)
WHEEZING	6/971 (0.6%)
PRODUCTIVE COUGH	4/971 (0.4%)
DYSPHONIA	3/971 (0.3%)
HICCUPS	3/971 (0.3%)
SINUS CONGESTION	3/971 (0.3%)
BRONCHOSPASM	2/971 (0.2%)
EPISTAXIS	2/971 (0.2%)
NASAL DRYNESS	2/971 (0.2%)
OROPHARYNGEAL PAIN	2/971 (0.2%)
PULMONARY OEDEMA	1/971 (0.1%)
RESPIRATORY DEPRESSION	2/971 (0.2%)
TACHYPNOEA	2/971 (0.2%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	1/971 (0.1%)
DYSPNOEA EXERTIONAL	1/971 (0.1%)
LUNG INFILTRATION	1/971 (0.1%)
NASAL DISCOMFORT	1/971 (0.1%)
PHARYNGEAL OEDEMA	1/971 (0.1%)
PLEURITIC PAIN	1/971 (0.1%)
PNEUMONIA ASPIRATION	1/971 (0.1%)
PULMONARY CONGESTION	1/971 (0.1%)
PULMONARY GRANULOMA	1/971 (0.1%)
PULMONARY HYPERTENSION	1/971 (0.1%)
RALES	1/971 (0.1%)
RESPIRATORY FAILURE	1/971 (0.1%)
RHINITIS ALLERGIC	1/971 (0.1%)
RHINORRHOEA	1/971 (0.1%)
SPUTUM DISCOLOURED	1/971 (0.1%)
Skin and subcutaneous tissue disorders
PRURITUS	125/971 (12.9%)
BLISTER	11/971 (1.1%)
RASH ERYTHEMATOUS	9/971 (0.9%)
HYPERHIDROSIS	7/971 (0.7%)
RASH	7/971 (0.7%)
PRURITUS GENERALISED	6/971 (0.6%)
ERYTHEMA	4/971 (0.4%)
DERMATITIS	3/971 (0.3%)
SKIN DISCOLOURATION	2/971 (0.2%)
ALOPECIA	1/971 (0.1%)
DECUBITUS ULCER	1/971 (0.1%)
DERMATITIS ALLERGIC	1/971 (0.1%)
DRY SKIN	1/971 (0.1%)
ECCHYMOSIS	1/971 (0.1%)
ECZEMA	1/971 (0.1%)
HYPOAESTHESIA FACIAL	1/971 (0.1%)
INGROWING NAIL	1/971 (0.1%)
LEUKOCYTOCLASTIC VASCULITIS	1/971 (0.1%)
PSORIASIS	1/971 (0.1%)
RASH MACULO-PAPULAR	1/971 (0.1%)
RASH PAPULAR	1/971 (0.1%)
ROSACEA	1/971 (0.1%)
STASIS DERMATITIS	1/971 (0.1%)
SWELLING FACE	1/971 (0.1%)
URTICARIA	1/971 (0.1%)
RASH PRURITIC	2/971 (0.2%)
Vascular disorders
HYPOTENSION	59/971 (6.1%)
HYPERTENSION	33/971 (3.4%)
DEEP VEIN THROMBOSIS	3/971 (0.3%)
FLUSHING	3/971 (0.3%)
WOUND HAEMORRHAGE	3/971 (0.3%)
DIASTOLIC HYPOTENSION	2/971 (0.2%)
HAEMATOMA	2/971 (0.2%)
HOT FLUSH	2/971 (0.2%)
HYPERTENSIVE CRISIS	1/971 (0.1%)
PALLOR	1/971 (0.1%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.