Special Investigation in Patients With Crohn's Disease (All Patients Investigation)

Sponsor

AbbVie (prior sponsor, Abbott) (Industry)

Overall Status

Completed

CT.gov ID

NCT01298648

Collaborator

(none)

1,716

Enrollment

1131

Locations

Duration (Months)

1.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will be conducted to assess adverse drug reactions, incidence of adverse events, and factors that may affect the safety and effectiveness of Humira for the treatment of Crohn's disease.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease

Study Design

Study Type:

Observational

Actual Enrollment :

1716 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Special Investigation (All Cases Investigation in Patients With Crohn's Disease)

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Humira Participants who were prescribed Humira per approved prescribing information of Humira in Japan.

Outcome Measures

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) [24 weeks]
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.
Crohn's Disease Activity Index (CDAI) at Baseline and Week 4 [Baseline, Week 4]
The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Crohn's Disease Activity Index (CDAI) at Baseline and Week 8 [Baseline, Week 8]
The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Crohn's Disease Activity Index (CDAI) at Baseline and Week 24 [Baseline, Week 24]
The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.

Secondary Outcome Measures

Improvement Rating by Investigator at Week 24 [Week 24]
Overall response rating, according to investigator's subjective clinical opinion. The level of improvement (markedly improved, improved, not improved, or not assessable) was categorized by comparing clinical condition at week 24 or at discontinuation with baseline condition.
Remission Rate at Week 4, Week 8, and Week 24 [Baseline, Week 4, Week 8, and Week 24]
The remission rate for each evaluation timepoint (Weeks 4, 8, and 24) was calculated as the number of participants that had CDAI < 150 divided by the number of participants at Baseline that had CDAI scores ≥ 150.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients with moderate or severe active Crohn's disease who are not responding well to conventional therapy and receive Humira will be enrolled in the survey

Exclusion Criteria:

Contraindications according to the Package Insert

Patients who have serious infections
Patients who have tuberculosis
Patients with a history of hypersensitivity to any ingredient of Humira
Patients who have demyelinating disease or with a history of demyelinating disease
Patients who have congestive cardiac failure

Contacts and Locations

Locations

	Site	City	Country
1	Site Reference ID/Investigator# 60378	Abiko	Japan
2	Site Reference ID/Investigator# 48682	Aichi	Japan
3	Site Reference ID/Investigator# 48693	Aichi	Japan
4	Site Reference ID/Investigator# 49011	Aichi	Japan
5	Site Reference ID/Investigator# 49013	Aichi	Japan
6	Site Reference ID/Investigator# 49015	Aichi	Japan
7	Site Reference ID/Investigator# 49016	Aichi	Japan
8	Site Reference ID/Investigator# 49019	Aichi	Japan
9	Site Reference ID/Investigator# 55615	Aichi	Japan
10	Site Reference ID/Investigator# 55616	Aichi	Japan
11	Site Reference ID/Investigator# 55865	Aichi	Japan
12	Site Reference ID/Investigator# 55869	Aichi	Japan
13	Site Reference ID/Investigator# 55870	Aichi	Japan
14	Site Reference ID/Investigator# 55871	Aichi	Japan
15	Site Reference ID/Investigator# 55872	Aichi	Japan
16	Site Reference ID/Investigator# 55873	Aichi	Japan
17	Site Reference ID/Investigator# 55874	Aichi	Japan
18	Site Reference ID/Investigator# 55875	Aichi	Japan
19	Site Reference ID/Investigator# 55876	Aichi	Japan
20	Site Reference ID/Investigator# 55877	Aichi	Japan
21	Site Reference ID/Investigator# 60203	Aichi	Japan
22	Site Reference ID/Investigator# 60205	Aichi	Japan
23	Site Reference ID/Investigator# 60244	Aichi	Japan
24	Site Reference ID/Investigator# 60508	Aichi	Japan
25	Site Reference ID/Investigator# 65148	Aichi	Japan
26	Site Reference ID/Investigator# 67162	Aichi	Japan
27	Site Reference ID/Investigator# 48652	Aizuwakamatsu	Japan
28	Site Reference ID/Investigator# 55758	Akashi	Japan
29	Site Reference ID/Investigator# 89873	Akashi	Japan
30	Site Reference ID/Investigator# 60398	Aki-gun, Hiroshima	Japan
31	Site Reference ID/Investigator# 60401	Aki-gun, Hiroshima	Japan
32	Site Reference ID/Investigator# 48650	Akita	Japan
33	Site Reference ID/Investigator# 55660	Akita	Japan
34	Site Reference ID/Investigator# 55705	Akita	Japan
35	Site Reference ID/Investigator# 55905	Akita	Japan
36	Site Reference ID/Investigator# 55906	Akita	Japan
37	Site Reference ID/Investigator# 55907	Akita	Japan
38	Site Reference ID/Investigator# 55909	Akita	Japan
39	Site Reference ID/Investigator# 60190	Akita	Japan
40	Site Reference ID/Investigator# 60261	Akita	Japan
41	Site Reference ID/Investigator# 60376	Akita	Japan
42	Site Reference ID/Investigator# 55742	Amagasaki	Japan
43	Site Reference ID/Investigator# 56030	Anan	Japan
44	Site Reference ID/Investigator# 49026	Anjo	Japan
45	Site Reference ID/Investigator# 55617	Anjo	Japan
46	Site Reference ID/Investigator# 48797	Aomori	Japan
47	Site Reference ID/Investigator# 55584	Aomori	Japan
48	Site Reference ID/Investigator# 55585	Aomori	Japan
49	Site Reference ID/Investigator# 55897	Aomori	Japan
50	Site Reference ID/Investigator# 55898	Aomori	Japan
51	Site Reference ID/Investigator# 55899	Aomori	Japan
52	Site Reference ID/Investigator# 55900	Aomori	Japan
53	Site Reference ID/Investigator# 60509	Aomori	Japan
54	Site Reference ID/Investigator# 65111	Aomori	Japan
55	Site Reference ID/Investigator# 65144	Aomori	Japan
56	Site Reference ID/Investigator# 80014	Aomori	Japan
57	Site Reference ID/Investigator# 48648	Asahikawa	Japan
58	Site Reference ID/Investigator# 55797	Asahikawa	Japan
59	Site Reference ID/Investigator# 56032	Awa	Japan
60	Site Reference ID/Investigator# 55778	Ayabe	Japan
61	Site Reference ID/Investigator# 80233	Azumino	Japan
62	Site Reference ID/Investigator# 80220	Beppu	Japan
63	Site Reference ID/Investigator# 48668	Chiba	Japan
64	Site Reference ID/Investigator# 48672	Chiba	Japan
65	Site Reference ID/Investigator# 49000	Chiba	Japan
66	Site Reference ID/Investigator# 49002	Chiba	Japan
67	Site Reference ID/Investigator# 49006	Chiba	Japan
68	Site Reference ID/Investigator# 55647	Chiba	Japan
69	Site Reference ID/Investigator# 55796	Chiba	Japan
70	Site Reference ID/Investigator# 55820	Chiba	Japan
71	Site Reference ID/Investigator# 55821	Chiba	Japan
72	Site Reference ID/Investigator# 55822	Chiba	Japan
73	Site Reference ID/Investigator# 55826	Chiba	Japan
74	Site Reference ID/Investigator# 55827	Chiba	Japan
75	Site Reference ID/Investigator# 55841	Chiba	Japan
76	Site Reference ID/Investigator# 60257	Chiba	Japan
77	Site Reference ID/Investigator# 65115	Chiba	Japan
78	Site Reference ID/Investigator# 65116	Chiba	Japan
79	Site Reference ID/Investigator# 65117	Chiba	Japan
80	Site Reference ID/Investigator# 65138	Chiba	Japan
81	Site Reference ID/Investigator# 67169	Chiba	Japan
82	Site Reference ID/Investigator# 79900	Chiba	Japan
83	Site Reference ID/Investigator# 89820	Chichibu	Japan
84	Site Reference ID/Investigator# 49074	Chikushino	Japan
85	Site Reference ID/Investigator# 55880	Chita	Japan
86	Site Reference ID/Investigator# 60210	Chita	Japan
87	Site Reference ID/Investigator# 55886	Chitose	Japan
88	Site Reference ID/Investigator# 55920	Chuo	Japan
89	Site Reference ID/Investigator# 80236	Ebetsu	Japan
90	Site Reference ID/Investigator# 49076	Ehime	Japan
91	Site Reference ID/Investigator# 55583	Ehime	Japan
92	Site Reference ID/Investigator# 56026	Ehime	Japan
93	Site Reference ID/Investigator# 56044	Ehime	Japan
94	Site Reference ID/Investigator# 65155	Ehime	Japan
95	Site Reference ID/Investigator# 67156	Eiheiji	Japan
96	Site Reference ID/Investigator# 79935	Esashi	Japan
97	Site Reference ID/Investigator# 48688	Fujieda	Japan
98	Site Reference ID/Investigator# 48689	Fujinomiya	Japan
99	Site Reference ID/Investigator# 79876	Fujisawa	Japan
100	Site Reference ID/Investigator# 89827	Fuji	Japan
101	Site Reference ID/Investigator# 48744	Fukui	Japan
102	Site Reference ID/Investigator# 55190	Fukui	Japan
103	Site Reference ID/Investigator# 55312	Fukui	Japan
104	Site Reference ID/Investigator# 55771	Fukui	Japan
105	Site Reference ID/Investigator# 55793	Fukui	Japan
106	Site Reference ID/Investigator# 80234	Fukui	Japan
107	Site Reference ID/Investigator# 48760	Fukuoka	Japan
108	Site Reference ID/Investigator# 48761	Fukuoka	Japan
109	Site Reference ID/Investigator# 48762	Fukuoka	Japan
110	Site Reference ID/Investigator# 48763	Fukuoka	Japan
111	Site Reference ID/Investigator# 48764	Fukuoka	Japan
112	Site Reference ID/Investigator# 48767	Fukuoka	Japan
113	Site Reference ID/Investigator# 48784	Fukuoka	Japan
114	Site Reference ID/Investigator# 49069	Fukuoka	Japan
115	Site Reference ID/Investigator# 49080	Fukuoka	Japan
116	Site Reference ID/Investigator# 49083	Fukuoka	Japan
117	Site Reference ID/Investigator# 49084	Fukuoka	Japan
118	Site Reference ID/Investigator# 49086	Fukuoka	Japan
119	Site Reference ID/Investigator# 55305	Fukuoka	Japan
120	Site Reference ID/Investigator# 56036	Fukuoka	Japan
121	Site Reference ID/Investigator# 56037	Fukuoka	Japan
122	Site Reference ID/Investigator# 56040	Fukuoka	Japan
123	Site Reference ID/Investigator# 56041	Fukuoka	Japan
124	Site Reference ID/Investigator# 56042	Fukuoka	Japan
125	Site Reference ID/Investigator# 56043	Fukuoka	Japan
126	Site Reference ID/Investigator# 56048	Fukuoka	Japan
127	Site Reference ID/Investigator# 56052	Fukuoka	Japan
128	Site Reference ID/Investigator# 60426	Fukuoka	Japan
129	Site Reference ID/Investigator# 60530	Fukuoka	Japan
130	Site Reference ID/Investigator# 60558	Fukuoka	Japan
131	Site Reference ID/Investigator# 65130	Fukuoka	Japan
132	Site Reference ID/Investigator# 65131	Fukuoka	Japan
133	Site Reference ID/Investigator# 65146	Fukuoka	Japan
134	Site Reference ID/Investigator# 65151	Fukuoka	Japan
135	Site Reference ID/Investigator# 68637	Fukuoka	Japan
136	Site Reference ID/Investigator# 68638	Fukuoka	Japan
137	Site Reference ID/Investigator# 90413	Fukuoka	Japan
138	Site Reference ID/Investigator# 48984	Fukushima	Japan
139	Site Reference ID/Investigator# 55163	Fukushima	Japan
140	Site Reference ID/Investigator# 55316	Fukushima	Japan
141	Site Reference ID/Investigator# 55597	Fukushima	Japan
142	Site Reference ID/Investigator# 55720	Fukushima	Japan
143	Site Reference ID/Investigator# 55798	Fukushima	Japan
144	Site Reference ID/Investigator# 55947	Fukushima	Japan
145	Site Reference ID/Investigator# 55948	Fukushima	Japan
146	Site Reference ID/Investigator# 55949	Fukushima	Japan
147	Site Reference ID/Investigator# 55950	Fukushima	Japan
148	Site Reference ID/Investigator# 55951	Fukushima	Japan
149	Site Reference ID/Investigator# 60196	Fukushima	Japan
150	Site Reference ID/Investigator# 60248	Fukushima	Japan
151	Site Reference ID/Investigator# 60386	Fukushima	Japan
152	Site Reference ID/Investigator# 60563	Fukushima	Japan
153	Site Reference ID/Investigator# 90396	Fukushima	Japan
154	Site Reference ID/Investigator# 55789	Fukuyama	Japan
155	Site Reference ID/Investigator# 56000	Fukuyama	Japan
156	Site Reference ID/Investigator# 90416	Fukuyama	Japan
157	Site Reference ID/Investigator# 48697	Gifu	Japan
158	Site Reference ID/Investigator# 49020	Gifu	Japan
159	Site Reference ID/Investigator# 49022	Gifu	Japan
160	Site Reference ID/Investigator# 55319	Gifu	Japan
161	Site Reference ID/Investigator# 55620	Gifu	Japan
162	Site Reference ID/Investigator# 55621	Gifu	Japan
163	Site Reference ID/Investigator# 55624	Gifu	Japan
164	Site Reference ID/Investigator# 55626	Gifu	Japan
165	Site Reference ID/Investigator# 55627	Gifu	Japan
166	Site Reference ID/Investigator# 55629	Gifu	Japan
167	Site Reference ID/Investigator# 60246	Gifu	Japan
168	Site Reference ID/Investigator# 60258	Gifu	Japan
169	Site Reference ID/Investigator# 60262	Gifu	Japan
170	Site Reference ID/Investigator# 60368	Gifu	Japan
171	Site Reference ID/Investigator# 60387	Gifu	Japan
172	Site Reference ID/Investigator# 60412	Gifu	Japan
173	Site Reference ID/Investigator# 60423	Gifu	Japan
174	Site Reference ID/Investigator# 60556	Gifu	Japan
175	Site Reference ID/Investigator# 60559	Gifu	Japan
176	Site Reference ID/Investigator# 67159	Gifu	Japan
177	Site Reference ID/Investigator# 48998	Gunma	Japan
178	Site Reference ID/Investigator# 55965	Gunma	Japan
179	Site Reference ID/Investigator# 55966	Gunma	Japan
180	Site Reference ID/Investigator# 55968	Gunma	Japan
181	Site Reference ID/Investigator# 60192	Gunma	Japan
182	Site Reference ID/Investigator# 60214	Gunma	Japan
183	Site Reference ID/Investigator# 60380	Gunma	Japan
184	Site Reference ID/Investigator# 65105	Gunma	Japan
185	Site Reference ID/Investigator# 67157	Gunma	Japan
186	Site Reference ID/Investigator# 67158	Gunma	Japan
187	Site Reference ID/Investigator# 55902	Hachinohe	Japan
188	Site Reference ID/Investigator# 60363	Hachinohe	Japan
189	Site Reference ID/Investigator# 48646	Hakodate	Japan
190	Site Reference ID/Investigator# 89856	Hakodate	Japan
191	Site Reference ID/Investigator# 48690	Hamamatsu	Japan
192	Site Reference ID/Investigator# 48691	Hamamatsu	Japan
193	Site Reference ID/Investigator# 55317	Hamamatsu	Japan
194	Site Reference ID/Investigator# 55613	Hamamatsu	Japan
195	Site Reference ID/Investigator# 55790	Hamamatsu	Japan
196	Site Reference ID/Investigator# 89817	Hamamatsu	Japan
197	Site Reference ID/Investigator# 55622	Hashima	Japan
198	Site Reference ID/Investigator# 55623	Hashima	Japan
199	Site Reference ID/Investigator# 56001	Higashihiroshima	Japan
200	Site Reference ID/Investigator# 55794	Higashiosaka	Japan
201	Site Reference ID/Investigator# 71467	Higashiosaka	Japan
202	Site Reference ID/Investigator# 55593	Himeji	Japan
203	Site Reference ID/Investigator# 55599	Himeji	Japan
204	Site Reference ID/Investigator# 55703	Himeji	Japan
205	Site Reference ID/Investigator# 90401	Himeji	Japan
206	Site Reference ID/Investigator# 55650	Hirakata	Japan
207	Site Reference ID/Investigator# 55311	Hirosaki	Japan
208	Site Reference ID/Investigator# 89813	Hirosaki	Japan
209	Site Reference ID/Investigator# 48751	Hiroshima	Japan
210	Site Reference ID/Investigator# 49063	Hiroshima	Japan
211	Site Reference ID/Investigator# 49064	Hiroshima	Japan
212	Site Reference ID/Investigator# 49068	Hiroshima	Japan
213	Site Reference ID/Investigator# 55164	Hiroshima	Japan
214	Site Reference ID/Investigator# 55574	Hiroshima	Japan
215	Site Reference ID/Investigator# 55581	Hiroshima	Japan
216	Site Reference ID/Investigator# 55601	Hiroshima	Japan
217	Site Reference ID/Investigator# 55694	Hiroshima	Japan
218	Site Reference ID/Investigator# 55997	Hiroshima	Japan
219	Site Reference ID/Investigator# 56002	Hiroshima	Japan
220	Site Reference ID/Investigator# 56003	Hiroshima	Japan
221	Site Reference ID/Investigator# 56004	Hiroshima	Japan
222	Site Reference ID/Investigator# 56005	Hiroshima	Japan
223	Site Reference ID/Investigator# 56007	Hiroshima	Japan
224	Site Reference ID/Investigator# 56008	Hiroshima	Japan
225	Site Reference ID/Investigator# 56010	Hiroshima	Japan
226	Site Reference ID/Investigator# 56014	Hiroshima	Japan
227	Site Reference ID/Investigator# 60554	Hiroshima	Japan
228	Site Reference ID/Investigator# 60560	Hiroshima	Japan
229	Site Reference ID/Investigator# 55588	Hitachi	Japan
230	Site Reference ID/Investigator# 56068	Hitoyoshi	Japan
231	Site Reference ID/Investigator# 48643	Hokkaido	Japan
232	Site Reference ID/Investigator# 48644	Hokkaido	Japan
233	Site Reference ID/Investigator# 48645	Hokkaido	Japan
234	Site Reference ID/Investigator# 48788	Hokkaido	Japan
235	Site Reference ID/Investigator# 48792	Hokkaido	Japan
236	Site Reference ID/Investigator# 48793	Hokkaido	Japan
237	Site Reference ID/Investigator# 48795	Hokkaido	Japan
238	Site Reference ID/Investigator# 48796	Hokkaido	Japan
239	Site Reference ID/Investigator# 55315	Hokkaido	Japan
240	Site Reference ID/Investigator# 55785	Hokkaido	Japan
241	Site Reference ID/Investigator# 55791	Hokkaido	Japan
242	Site Reference ID/Investigator# 55804	Hokkaido	Japan
243	Site Reference ID/Investigator# 55878	Hokkaido	Japan
244	Site Reference ID/Investigator# 55885	Hokkaido	Japan
245	Site Reference ID/Investigator# 55887	Hokkaido	Japan
246	Site Reference ID/Investigator# 55888	Hokkaido	Japan
247	Site Reference ID/Investigator# 55889	Hokkaido	Japan
248	Site Reference ID/Investigator# 55891	Hokkaido	Japan
249	Site Reference ID/Investigator# 55892	Hokkaido	Japan
250	Site Reference ID/Investigator# 55893	Hokkaido	Japan
251	Site Reference ID/Investigator# 55894	Hokkaido	Japan
252	Site Reference ID/Investigator# 55895	Hokkaido	Japan
253	Site Reference ID/Investigator# 60193	Hokkaido	Japan
254	Site Reference ID/Investigator# 60201	Hokkaido	Japan
255	Site Reference ID/Investigator# 60540	Hokkaido	Japan
256	Site Reference ID/Investigator# 60552	Hokkaido	Japan
257	Site Reference ID/Investigator# 60557	Hokkaido	Japan
258	Site Reference ID/Investigator# 65109	Hokkaido	Japan
259	Site Reference ID/Investigator# 65110	Hokkaido	Japan
260	Site Reference ID/Investigator# 48755	Houfu	Japan
261	Site Reference ID/Investigator# 80219	Houfu	Japan
262	Site Reference ID/Investigator# 48707	Hyogo	Japan
263	Site Reference ID/Investigator# 48708	Hyogo	Japan
264	Site Reference ID/Investigator# 48710	Hyogo	Japan
265	Site Reference ID/Investigator# 48712	Hyogo	Japan
266	Site Reference ID/Investigator# 48713	Hyogo	Japan
267	Site Reference ID/Investigator# 49042	Hyogo	Japan
268	Site Reference ID/Investigator# 49046	Hyogo	Japan
269	Site Reference ID/Investigator# 49047	Hyogo	Japan
270	Site Reference ID/Investigator# 55156	Hyogo	Japan
271	Site Reference ID/Investigator# 55691	Hyogo	Japan
272	Site Reference ID/Investigator# 55743	Hyogo	Japan
273	Site Reference ID/Investigator# 55744	Hyogo	Japan
274	Site Reference ID/Investigator# 55746	Hyogo	Japan
275	Site Reference ID/Investigator# 55748	Hyogo	Japan
276	Site Reference ID/Investigator# 55749	Hyogo	Japan
277	Site Reference ID/Investigator# 55750	Hyogo	Japan
278	Site Reference ID/Investigator# 55752	Hyogo	Japan
279	Site Reference ID/Investigator# 55753	Hyogo	Japan
280	Site Reference ID/Investigator# 55755	Hyogo	Japan
281	Site Reference ID/Investigator# 55756	Hyogo	Japan
282	Site Reference ID/Investigator# 55757	Hyogo	Japan
283	Site Reference ID/Investigator# 55759	Hyogo	Japan
284	Site Reference ID/Investigator# 60215	Hyogo	Japan
285	Site Reference ID/Investigator# 60224	Hyogo	Japan
286	Site Reference ID/Investigator# 60251	Hyogo	Japan
287	Site Reference ID/Investigator# 60364	Hyogo	Japan
288	Site Reference ID/Investigator# 60388	Hyogo	Japan
289	Site Reference ID/Investigator# 60389	Hyogo	Japan
290	Site Reference ID/Investigator# 60402	Hyogo	Japan
291	Site Reference ID/Investigator# 60528	Hyogo	Japan
292	Site Reference ID/Investigator# 60531	Hyogo	Japan
293	Site Reference ID/Investigator# 65143	Hyogo	Japan
294	Site Reference ID/Investigator# 68641	Hyogo	Japan
295	Site Reference ID/Investigator# 48991	Ibaraki-ken	Japan
296	Site Reference ID/Investigator# 48994	Ibaraki	Japan
297	Site Reference ID/Investigator# 49008	Ibaraki	Japan
298	Site Reference ID/Investigator# 55596	Ibaraki	Japan
299	Site Reference ID/Investigator# 55693	Ibaraki	Japan
300	Site Reference ID/Investigator# 55955	Ibaraki	Japan
301	Site Reference ID/Investigator# 55957	Ibaraki	Japan
302	Site Reference ID/Investigator# 55958	Ibaraki	Japan
303	Site Reference ID/Investigator# 55959	Ibaraki	Japan
304	Site Reference ID/Investigator# 60253	Ibaraki	Japan
305	Site Reference ID/Investigator# 60362	Ibaraki	Japan
306	Site Reference ID/Investigator# 60407	Ibaraki	Japan
307	Site Reference ID/Investigator# 60524	Ibaraki	Japan
308	Site Reference ID/Investigator# 55824	Ichihara	Japan
309	Site Reference ID/Investigator# 55825	Ichihara	Japan
310	Site Reference ID/Investigator# 48667	Ichikawa	Japan
311	Site Reference ID/Investigator# 60513	Ichinomiya	Japan
312	Site Reference ID/Investigator# 60216	Ichinoseki	Japan
313	Site Reference ID/Investigator# 90415	Ichinoseki	Japan
314	Site Reference ID/Investigator# 49078	Iizuka	Japan
315	Site Reference ID/Investigator# 55685	Ikoma	Japan
316	Site Reference ID/Investigator# 49043	Ikomo, Nara	Japan
317	Site Reference ID/Investigator# 55313	Imabari	Japan
318	Site Reference ID/Investigator# 55704	Inashiki	Japan
319	Site Reference ID/Investigator# 94893	Inazawa	Japan
320	Site Reference ID/Investigator# 80222	Ina	Japan
321	Site Reference ID/Investigator# 60510	Inzai	Japan
322	Site Reference ID/Investigator# 94804	Isa	Japan
323	Site Reference ID/Investigator# 94805	Isa	Japan
324	Site Reference ID/Investigator# 55571	Isehara	Japan
325	Site Reference ID/Investigator# 48657	Isesaki	Japan
326	Site Reference ID/Investigator# 49052	Ishikawa	Japan
327	Site Reference ID/Investigator# 55162	Ishikawa	Japan
328	Site Reference ID/Investigator# 55765	Ishikawa	Japan
329	Site Reference ID/Investigator# 55767	Ishikawa	Japan
330	Site Reference ID/Investigator# 55768	Ishikawa	Japan
331	Site Reference ID/Investigator# 55769	Ishikawa	Japan
332	Site Reference ID/Investigator# 55770	Ishikawa	Japan
333	Site Reference ID/Investigator# 60555	Ishikawa	Japan
334	Site Reference ID/Investigator# 65125	Ishikawa	Japan
335	Site Reference ID/Investigator# 65126	Ishikawa	Japan
336	Site Reference ID/Investigator# 60375	Itami	Japan
337	Site Reference ID/Investigator# 55946	Iwaki	Japan
338	Site Reference ID/Investigator# 49060	Iwakuni	Japan
339	Site Reference ID/Investigator# 55612	Iwata	Japan
340	Site Reference ID/Investigator# 48647	Iwate	Japan
341	Site Reference ID/Investigator# 55842	Iwate	Japan
342	Site Reference ID/Investigator# 55903	Iwate	Japan
343	Site Reference ID/Investigator# 60223	Iwate	Japan
344	Site Reference ID/Investigator# 60249	Iwate	Japan
345	Site Reference ID/Investigator# 60263	Iwate	Japan
346	Site Reference ID/Investigator# 60394	Iwate	Japan
347	Site Reference ID/Investigator# 60538	Iwate	Japan
348	Site Reference ID/Investigator# 68639	Iwate	Japan
349	Site Reference ID/Investigator# 49048	Izumiotsu	Japan
350	Site Reference ID/Investigator# 55673	Izumisano	Japan
351	Site Reference ID/Investigator# 49061	Izumo	Japan
352	Site Reference ID/Investigator# 49062	Izumo	Japan
353	Site Reference ID/Investigator# 55882	Izunokuni	Japan
354	Site Reference ID/Investigator# 84095	Izunokuni	Japan
355	Site Reference ID/Investigator# 55954	Joetsu	Japan
356	Site Reference ID/Investigator# 79878	Jyoyo	Japan
357	Site Reference ID/Investigator# 55625	Kagamigahara	Japan
358	Site Reference ID/Investigator# 49070	Kagawa	Japan
359	Site Reference ID/Investigator# 55716	Kagawa	Japan
360	Site Reference ID/Investigator# 55782	Kagawa	Japan
361	Site Reference ID/Investigator# 55805	Kagawa	Japan
362	Site Reference ID/Investigator# 56017	Kagawa	Japan
363	Site Reference ID/Investigator# 56018	Kagawa	Japan
364	Site Reference ID/Investigator# 56019	Kagawa	Japan
365	Site Reference ID/Investigator# 56020	Kagawa	Japan
366	Site Reference ID/Investigator# 56021	Kagawa	Japan
367	Site Reference ID/Investigator# 56022	Kagawa	Japan
368	Site Reference ID/Investigator# 56025	Kagawa	Japan
369	Site Reference ID/Investigator# 60221	Kagawa	Japan
370	Site Reference ID/Investigator# 65129	Kagawa	Japan
371	Site Reference ID/Investigator# 48777	Kagoshima	Japan
372	Site Reference ID/Investigator# 48778	Kagoshima	Japan
373	Site Reference ID/Investigator# 48779	Kagoshima	Japan
374	Site Reference ID/Investigator# 49091	Kagoshima	Japan
375	Site Reference ID/Investigator# 49092	Kagoshima	Japan
376	Site Reference ID/Investigator# 56069	Kagoshima	Japan
377	Site Reference ID/Investigator# 56070	Kagoshima	Japan
378	Site Reference ID/Investigator# 56077	Kagoshima	Japan
379	Site Reference ID/Investigator# 56079	Kagoshima	Japan
380	Site Reference ID/Investigator# 60222	Kagoshima	Japan
381	Site Reference ID/Investigator# 60377	Kagoshima	Japan
382	Site Reference ID/Investigator# 60517	Kagoshima	Japan
383	Site Reference ID/Investigator# 65134	Kagoshima	Japan
384	Site Reference ID/Investigator# 65135	Kagoshima	Japan
385	Site Reference ID/Investigator# 94802	Kagoshima	Japan
386	Site Reference ID/Investigator# 65122	Kaizuka	Japan
387	Site Reference ID/Investigator# 89831	Kako	Japan
388	Site Reference ID/Investigator# 48680	Kamakura	Japan
389	Site Reference ID/Investigator# 49001	Kamogawa	Japan
390	Site Reference ID/Investigator# 84098	Kamo	Japan
391	Site Reference ID/Investigator# 55663	Kanagawa	Japan
392	Site Reference ID/Investigator# 55699	Kanagawa	Japan
393	Site Reference ID/Investigator# 55802	Kanagawa	Japan
394	Site Reference ID/Investigator# 55850	Kanagawa	Japan
395	Site Reference ID/Investigator# 55857	Kanagawa	Japan
396	Site Reference ID/Investigator# 55859	Kanagawa	Japan
397	Site Reference ID/Investigator# 55860	Kanagawa	Japan
398	Site Reference ID/Investigator# 55861	Kanagawa	Japan
399	Site Reference ID/Investigator# 55862	Kanagawa	Japan
400	Site Reference ID/Investigator# 55863	Kanagawa	Japan
401	Site Reference ID/Investigator# 55864	Kanagawa	Japan
402	Site Reference ID/Investigator# 60415	Kanagawa	Japan
403	Site Reference ID/Investigator# 60416	Kanagawa	Japan
404	Site Reference ID/Investigator# 60422	Kanagawa	Japan
405	Site Reference ID/Investigator# 60504	Kanagawa	Japan
406	Site Reference ID/Investigator# 60518	Kanagawa	Japan
407	Site Reference ID/Investigator# 60520	Kanagawa	Japan
408	Site Reference ID/Investigator# 60521	Kanagawa	Japan
409	Site Reference ID/Investigator# 60566	Kanagawa	Japan
410	Site Reference ID/Investigator# 55194	Kanazawa	Japan
411	Site Reference ID/Investigator# 55600	Kanazawa	Japan
412	Site Reference ID/Investigator# 55763	Kanazawa	Japan
413	Site Reference ID/Investigator# 55764	Kanazawa	Japan
414	Site Reference ID/Investigator# 55853	Kanazawa	Japan
415	Site Reference ID/Investigator# 79877	Kanazawa	Japan
416	Site Reference ID/Investigator# 84093	Kanazawa	Japan
417	Site Reference ID/Investigator# 48695	Kariya	Japan
418	Site Reference ID/Investigator# 55189	Kashihara	Japan
419	Site Reference ID/Investigator# 55602	Kashihara	Japan
420	Site Reference ID/Investigator# 48671	Kashiwa	Japan
421	Site Reference ID/Investigator# 84114	Kasukabe	Japan
422	Site Reference ID/Investigator# 84116	Kawachinagano	Japan
423	Site Reference ID/Investigator# 48704	Kawachinago	Japan
424	Site Reference ID/Investigator# 48675	Kawagoe	Japan
425	Site Reference ID/Investigator# 55844	Kawagoe	Japan
426	Site Reference ID/Investigator# 67154	Kawagoe	Japan
427	Site Reference ID/Investigator# 60523	Kawanishi	Japan
428	Site Reference ID/Investigator# 55324	Kawasaki	Japan
429	Site Reference ID/Investigator# 55843	Kawasaki	Japan
430	Site Reference ID/Investigator# 55851	Kawasaki	Japan
431	Site Reference ID/Investigator# 60533	Kawasaki	Japan
432	Site Reference ID/Investigator# 60542	Kawasaki	Japan
433	Site Reference ID/Investigator# 79953	Kawasaki	Japan
434	Site Reference ID/Investigator# 55614	Kikukawa	Japan
435	Site Reference ID/Investigator# 49095	Kirishima	Japan
436	Site Reference ID/Investigator# 55823	Kisarazu	Japan
437	Site Reference ID/Investigator# 48765	Kitakyushu	Japan
438	Site Reference ID/Investigator# 49077	Kitakyushu	Japan
439	Site Reference ID/Investigator# 49079	Kitakyushu	Japan
440	Site Reference ID/Investigator# 49081	Kitakyushu	Japan
441	Site Reference ID/Investigator# 55618	Kitakyushu	Japan
442	Site Reference ID/Investigator# 56039	Kitakyushu	Japan
443	Site Reference ID/Investigator# 60519	Kitakyushu	Japan
444	Site Reference ID/Investigator# 71473	Kitakyushu	Japan
445	Site Reference ID/Investigator# 60537	Kitakyusyu	Japan
446	Site Reference ID/Investigator# 48709	Kobe	Japan
447	Site Reference ID/Investigator# 55157	Kobe	Japan
448	Site Reference ID/Investigator# 55573	Kobe	Japan
449	Site Reference ID/Investigator# 55692	Kobe	Japan
450	Site Reference ID/Investigator# 55745	Kobe	Japan
451	Site Reference ID/Investigator# 55747	Kobe	Japan
452	Site Reference ID/Investigator# 55751	Kobe	Japan
453	Site Reference ID/Investigator# 48759	Kochi	Japan
454	Site Reference ID/Investigator# 49072	Kochi	Japan
455	Site Reference ID/Investigator# 55657	Kochi	Japan
456	Site Reference ID/Investigator# 55719	Kochi	Japan
457	Site Reference ID/Investigator# 56027	Kochi	Japan
458	Site Reference ID/Investigator# 56031	Kochi	Japan
459	Site Reference ID/Investigator# 56033	Kochi	Japan
460	Site Reference ID/Investigator# 56034	Kochi	Japan
461	Site Reference ID/Investigator# 60195	Kochi	Japan
462	Site Reference ID/Investigator# 60260	Kochi	Japan
463	Site Reference ID/Investigator# 60264	Kochi	Japan
464	Site Reference ID/Investigator# 60408	Kochi	Japan
465	Site Reference ID/Investigator# 55969	Kofu	Japan
466	Site Reference ID/Investigator# 79875	Kofu	Japan
467	Site Reference ID/Investigator# 48995	Koga	Japan
468	Site Reference ID/Investigator# 55924	Komagane	Japan
469	Site Reference ID/Investigator# 84097	Komaki	Japan
470	Site Reference ID/Investigator# 55766	Komatsu	Japan
471	Site Reference ID/Investigator# 55307	Konan	Japan
472	Site Reference ID/Investigator# 48654	Koriyama	Japan
473	Site Reference ID/Investigator# 55603	Koriyama	Japan
474	Site Reference ID/Investigator# 67265	Koriyama	Japan
475	Site Reference ID/Investigator# 80013	Koriyama	Japan
476	Site Reference ID/Investigator# 49017	Koshigaya	Japan
477	Site Reference ID/Investigator# 94800	Koshigaya	Japan
478	Site Reference ID/Investigator# 56016	Kudamatsu	Japan
479	Site Reference ID/Investigator# 55904	Kuji	Japan
480	Site Reference ID/Investigator# 48773	Kumamoto	Japan
481	Site Reference ID/Investigator# 48774	Kumamoto	Japan
482	Site Reference ID/Investigator# 48775	Kumamoto	Japan
483	Site Reference ID/Investigator# 48776	Kumamoto	Japan
484	Site Reference ID/Investigator# 48781	Kumamoto	Japan
485	Site Reference ID/Investigator# 49094	Kumamoto	Japan
486	Site Reference ID/Investigator# 56065	Kumamoto	Japan
487	Site Reference ID/Investigator# 56066	Kumamoto	Japan
488	Site Reference ID/Investigator# 56067	Kumamoto	Japan
489	Site Reference ID/Investigator# 56071	Kumamoto	Japan
490	Site Reference ID/Investigator# 60220	Kumamoto	Japan
491	Site Reference ID/Investigator# 60367	Kumamoto	Japan
492	Site Reference ID/Investigator# 60369	Kumamoto	Japan
493	Site Reference ID/Investigator# 60382	Kumamoto	Japan
494	Site Reference ID/Investigator# 60385	Kumamoto	Japan
495	Site Reference ID/Investigator# 60411	Kumamoto	Japan
496	Site Reference ID/Investigator# 60427	Kumamoto	Japan
497	Site Reference ID/Investigator# 60550	Kumamoto	Japan
498	Site Reference ID/Investigator# 65141	Kumamoto	Japan
499	Site Reference ID/Investigator# 79894	Kumamoto	Japan
500	Site Reference ID/Investigator# 79897	Kumamoto	Japan
501	Site Reference ID/Investigator# 84113	Kumamoto	Japan
502	Site Reference ID/Investigator# 48748	Kurashiki	Japan
503	Site Reference ID/Investigator# 55169	Kurashiki	Japan
504	Site Reference ID/Investigator# 67165	Kurashiki	Japan
505	Site Reference ID/Investigator# 56006	Kure	Japan
506	Site Reference ID/Investigator# 55761	Kurobe	Japan
507	Site Reference ID/Investigator# 48766	Kurume	Japan
508	Site Reference ID/Investigator# 48768	Kurume	Japan
509	Site Reference ID/Investigator# 56038	Kurume	Japan
510	Site Reference ID/Investigator# 55896	Kushiro	Japan
511	Site Reference ID/Investigator# 55773	Kyoto, Kyoto	Japan
512	Site Reference ID/Investigator# 49053	Kyoto-city	Japan
513	Site Reference ID/Investigator# 48745	Kyoto	Japan
514	Site Reference ID/Investigator# 48746	Kyoto	Japan
515	Site Reference ID/Investigator# 48747	Kyoto	Japan
516	Site Reference ID/Investigator# 49051	Kyoto	Japan
517	Site Reference ID/Investigator# 49054	Kyoto	Japan
518	Site Reference ID/Investigator# 55322	Kyoto	Japan
519	Site Reference ID/Investigator# 55577	Kyoto	Japan
520	Site Reference ID/Investigator# 55587	Kyoto	Japan
521	Site Reference ID/Investigator# 55661	Kyoto	Japan
522	Site Reference ID/Investigator# 55718	Kyoto	Japan
523	Site Reference ID/Investigator# 55772	Kyoto	Japan
524	Site Reference ID/Investigator# 55774	Kyoto	Japan
525	Site Reference ID/Investigator# 55775	Kyoto	Japan
526	Site Reference ID/Investigator# 55776	Kyoto	Japan
527	Site Reference ID/Investigator# 55828	Kyoto	Japan
528	Site Reference ID/Investigator# 55829	Kyoto	Japan
529	Site Reference ID/Investigator# 60213	Kyoto	Japan
530	Site Reference ID/Investigator# 60381	Kyoto	Japan
531	Site Reference ID/Investigator# 65102	Kyoto	Japan
532	Site Reference ID/Investigator# 65108	Kyoto	Japan
533	Site Reference ID/Investigator# 71470	Kyoto	Japan
534	Site Reference ID/Investigator# 79893	Kyoto	Japan
535	Site Reference ID/Investigator# 94801	Kyoto	Japan
536	Site Reference ID/Investigator# 49044	Machida	Japan
537	Site Reference ID/Investigator# 55185	Maebashi	Japan
538	Site Reference ID/Investigator# 55697	Maebashi	Japan
539	Site Reference ID/Investigator# 55964	Maebashi	Japan
540	Site Reference ID/Investigator# 71461	Maebashi	Japan
541	Site Reference ID/Investigator# 84198	Marugame	Japan
542	Site Reference ID/Investigator# 65147	Matsubushi	Japan
543	Site Reference ID/Investigator# 55831	Matsudo	Japan
544	Site Reference ID/Investigator# 55832	Matsudo	Japan
545	Site Reference ID/Investigator# 55715	Matsue	Japan
546	Site Reference ID/Investigator# 48780	Matsumoto	Japan
547	Site Reference ID/Investigator# 55159	Matsumoto	Japan
548	Site Reference ID/Investigator# 48757	Matsuyama	Japan
549	Site Reference ID/Investigator# 48758	Matsuyama	Japan
550	Site Reference ID/Investigator# 49071	Matsuyama	Japan
551	Site Reference ID/Investigator# 56024	Matsuyama	Japan
552	Site Reference ID/Investigator# 60553	Matsuyama	Japan
553	Site Reference ID/Investigator# 90417	Matsuyama	Japan
554	Site Reference ID/Investigator# 55960	Mibu	Japan
555	Site Reference ID/Investigator# 55967	Midori	Japan
556	Site Reference ID/Investigator# 49024	Mie	Japan
557	Site Reference ID/Investigator# 55632	Mie	Japan
558	Site Reference ID/Investigator# 55633	Mie	Japan
559	Site Reference ID/Investigator# 55634	Mie	Japan
560	Site Reference ID/Investigator# 55635	Mie	Japan
561	Site Reference ID/Investigator# 55636	Mie	Japan
562	Site Reference ID/Investigator# 55637	Mie	Japan
563	Site Reference ID/Investigator# 65119	Mie	Japan
564	Site Reference ID/Investigator# 80225	Minato	Japan
565	Site Reference ID/Investigator# 49021	Mishima	Japan
566	Site Reference ID/Investigator# 55161	Mitaka	Japan
567	Site Reference ID/Investigator# 55572	Mitaka	Japan
568	Site Reference ID/Investigator# 48656	Mito	Japan
569	Site Reference ID/Investigator# 48651	Miyagi	Japan
570	Site Reference ID/Investigator# 48653	Miyagi	Japan
571	Site Reference ID/Investigator# 48655	Miyagi	Japan
572	Site Reference ID/Investigator# 55917	Miyagi	Japan
573	Site Reference ID/Investigator# 55918	Miyagi	Japan
574	Site Reference ID/Investigator# 55929	Miyagi	Japan
575	Site Reference ID/Investigator# 55930	Miyagi	Japan
576	Site Reference ID/Investigator# 55931	Miyagi	Japan
577	Site Reference ID/Investigator# 55932	Miyagi	Japan
578	Site Reference ID/Investigator# 55942	Miyagi	Japan
579	Site Reference ID/Investigator# 55943	Miyagi	Japan
580	Site Reference ID/Investigator# 60207	Miyagi	Japan
581	Site Reference ID/Investigator# 60208	Miyagi	Japan
582	Site Reference ID/Investigator# 60379	Miyagi	Japan
583	Site Reference ID/Investigator# 60384	Miyagi	Japan
584	Site Reference ID/Investigator# 60561	Miyagi	Japan
585	Site Reference ID/Investigator# 65150	Miyagi	Japan
586	Site Reference ID/Investigator# 67161	Miyagi	Japan
587	Site Reference ID/Investigator# 67164	Miyagi	Japan
588	Site Reference ID/Investigator# 56055	Miyazaki	Japan
589	Site Reference ID/Investigator# 56060	Miyazaki	Japan
590	Site Reference ID/Investigator# 56061	Miyazaki	Japan
591	Site Reference ID/Investigator# 56063	Miyazaki	Japan
592	Site Reference ID/Investigator# 56064	Miyazaki	Japan
593	Site Reference ID/Investigator# 80033	Miyazaki	Japan
594	Site Reference ID/Investigator# 89837	Monbetsu	Japan
595	Site Reference ID/Investigator# 49032	Moriguchi	Japan
596	Site Reference ID/Investigator# 48649	Morioka	Japan
597	Site Reference ID/Investigator# 89823	Morioka	Japan
598	Site Reference ID/Investigator# 89835	Morioka	Japan
599	Site Reference ID/Investigator# 90414	Morioka	Japan
600	Site Reference ID/Investigator# 55983	Moriyama	Japan
601	Site Reference ID/Investigator# 89819	Moriya	Japan
602	Site Reference ID/Investigator# 60535	Munakata	Japan
603	Site Reference ID/Investigator# 55890	Muroran	Japan
604	Site Reference ID/Investigator# 90399	Muroran	Japan
605	Site Reference ID/Investigator# 60532	Musashino	Japan
606	Site Reference ID/Investigator# 55586	Nagahama	Japan
607	Site Reference ID/Investigator# 48685	Nagakute	Japan
608	Site Reference ID/Investigator# 55707	Nagano	Japan
609	Site Reference ID/Investigator# 55708	Nagano	Japan
610	Site Reference ID/Investigator# 55921	Nagano	Japan
611	Site Reference ID/Investigator# 55922	Nagano	Japan
612	Site Reference ID/Investigator# 55923	Nagano	Japan
613	Site Reference ID/Investigator# 60507	Nagano	Japan
614	Site Reference ID/Investigator# 60564	Nagano	Japan
615	Site Reference ID/Investigator# 48989	Nagaoka	Japan
616	Site Reference ID/Investigator# 55582	Nagaoka	Japan
617	Site Reference ID/Investigator# 80235	Nagareyama	Japan
618	Site Reference ID/Investigator# 48769	Nagasaki	Japan
619	Site Reference ID/Investigator# 48770	Nagasaki	Japan
620	Site Reference ID/Investigator# 48782	Nagasaki	Japan
621	Site Reference ID/Investigator# 49082	Nagasaki	Japan
622	Site Reference ID/Investigator# 55866	Nagasaki	Japan
623	Site Reference ID/Investigator# 56053	Nagasaki	Japan
624	Site Reference ID/Investigator# 56058	Nagasaki	Japan
625	Site Reference ID/Investigator# 60211	Nagasaki	Japan
626	Site Reference ID/Investigator# 60217	Nagasaki	Japan
627	Site Reference ID/Investigator# 60252	Nagasaki	Japan
628	Site Reference ID/Investigator# 60266	Nagasaki	Japan
629	Site Reference ID/Investigator# 60545	Nagasaki	Japan
630	Site Reference ID/Investigator# 65132	Nagasaki	Japan
631	Site Reference ID/Investigator# 65133	Nagasaki	Japan
632	Site Reference ID/Investigator# 79873	Nagasaki	Japan
633	Site Reference ID/Investigator# 94799	Nagasaki	Japan
634	Site Reference ID/Investigator# 56011	Nagato	Japan
635	Site Reference ID/Investigator# 48683	Nagoya	Japan
636	Site Reference ID/Investigator# 48684	Nagoya	Japan
637	Site Reference ID/Investigator# 48692	Nagoya	Japan
638	Site Reference ID/Investigator# 55608	Nagoya	Japan
639	Site Reference ID/Investigator# 55800	Nagoya	Japan
640	Site Reference ID/Investigator# 60199	Nagoya	Japan
641	Site Reference ID/Investigator# 65107	Nagoya	Japan
642	Site Reference ID/Investigator# 71463	Nagoya	Japan
643	Site Reference ID/Investigator# 71466	Nagoya	Japan
644	Site Reference ID/Investigator# 80223	Nagoya	Japan
645	Site Reference ID/Investigator# 84115	Nagoya	Japan
646	Site Reference ID/Investigator# 89826	Nagoya	Japan
647	Site Reference ID/Investigator# 89828	Nagoya	Japan
648	Site Reference ID/Investigator# 94892	Nagoya	Japan
649	Site Reference ID/Investigator# 71468	Naha	Japan
650	Site Reference ID/Investigator# 55783	Nankoku	Japan
651	Site Reference ID/Investigator# 89860	Nankoku	Japan
652	Site Reference ID/Investigator# 48669	Narashino	Japan
653	Site Reference ID/Investigator# 55701	Narashino	Japan
654	Site Reference ID/Investigator# 55680	Nara	Japan
655	Site Reference ID/Investigator# 55681	Nara	Japan
656	Site Reference ID/Investigator# 55682	Nara	Japan
657	Site Reference ID/Investigator# 55683	Nara	Japan
658	Site Reference ID/Investigator# 55684	Nara	Japan
659	Site Reference ID/Investigator# 94889	Nara	Japan
660	Site Reference ID/Investigator# 55788	Narita	Japan
661	Site Reference ID/Investigator# 79898	Nasushiobara	Japan
662	Site Reference ID/Investigator# 60421	Neyagawa	Japan
663	Site Reference ID/Investigator# 48983	Niigata	Japan
664	Site Reference ID/Investigator# 48985	Niigata	Japan
665	Site Reference ID/Investigator# 48987	Niigata	Japan
666	Site Reference ID/Investigator# 48988	Niigata	Japan
667	Site Reference ID/Investigator# 48990	Niigata	Japan
668	Site Reference ID/Investigator# 49025	Niigata	Japan
669	Site Reference ID/Investigator# 55158	Niigata	Japan
670	Site Reference ID/Investigator# 55320	Niigata	Japan
671	Site Reference ID/Investigator# 55619	Niigata	Japan
672	Site Reference ID/Investigator# 55646	Niigata	Japan
673	Site Reference ID/Investigator# 55952	Niigata	Japan
674	Site Reference ID/Investigator# 55953	Niigata	Japan
675	Site Reference ID/Investigator# 65112	Niigata	Japan
676	Site Reference ID/Investigator# 49096	Nishihara	Japan
677	Site Reference ID/Investigator# 48711	Nishinomiya	Japan
678	Site Reference ID/Investigator# 48785	Nishinomiya	Japan
679	Site Reference ID/Investigator# 48786	Nishinomiya	Japan
680	Site Reference ID/Investigator# 55803	Nishinomiya	Japan
681	Site Reference ID/Investigator# 65124	Nishinomiya	Japan
682	Site Reference ID/Investigator# 67160	Nishitokyo	Japan
683	Site Reference ID/Investigator# 71471	Nobeoka	Japan
684	Site Reference ID/Investigator# 84094	Nomi	Japan
685	Site Reference ID/Investigator# 90394	Numata	Japan
686	Site Reference ID/Investigator# 48794	Obihiro	Japan
687	Site Reference ID/Investigator# 94894	Obihiro	Japan
688	Site Reference ID/Investigator# 55187	Odawara	Japan
689	Site Reference ID/Investigator# 89853	Ofunato	Japan
690	Site Reference ID/Investigator# 48696	Ogaki	Japan
691	Site Reference ID/Investigator# 48772	Oita	Japan
692	Site Reference ID/Investigator# 49087	Oita	Japan
693	Site Reference ID/Investigator# 49088	Oita	Japan
694	Site Reference ID/Investigator# 49089	Oita	Japan
695	Site Reference ID/Investigator# 49090	Oita	Japan
696	Site Reference ID/Investigator# 49093	Oita	Japan
697	Site Reference ID/Investigator# 55607	Oita	Japan
698	Site Reference ID/Investigator# 56054	Oita	Japan
699	Site Reference ID/Investigator# 56056	Oita	Japan
700	Site Reference ID/Investigator# 56059	Oita	Japan
701	Site Reference ID/Investigator# 56062	Oita	Japan
702	Site Reference ID/Investigator# 60206	Oita	Japan
703	Site Reference ID/Investigator# 60410	Oita	Japan
704	Site Reference ID/Investigator# 67163	Oita	Japan
705	Site Reference ID/Investigator# 68636	Oita	Japan
706	Site Reference ID/Investigator# 89836	Oita	Japan
707	Site Reference ID/Investigator# 48749	Okayama	Japan
708	Site Reference ID/Investigator# 49055	Okayama	Japan
709	Site Reference ID/Investigator# 49056	Okayama	Japan
710	Site Reference ID/Investigator# 49059	Okayama	Japan
711	Site Reference ID/Investigator# 55984	Okayama	Japan
712	Site Reference ID/Investigator# 55988	Okayama	Japan
713	Site Reference ID/Investigator# 55989	Okayama	Japan
714	Site Reference ID/Investigator# 55990	Okayama	Japan
715	Site Reference ID/Investigator# 55991	Okayama	Japan
716	Site Reference ID/Investigator# 55992	Okayama	Japan
717	Site Reference ID/Investigator# 55995	Okayama	Japan
718	Site Reference ID/Investigator# 60390	Okayama	Japan
719	Site Reference ID/Investigator# 60527	Okayama	Japan
720	Site Reference ID/Investigator# 60529	Okayama	Japan
721	Site Reference ID/Investigator# 65127	Okayama	Japan
722	Site Reference ID/Investigator# 89822	Okayama	Japan
723	Site Reference ID/Investigator# 90398	Okayama	Japan
724	Site Reference ID/Investigator# 49097	Okinawa	Japan
725	Site Reference ID/Investigator# 55702	Okinawa	Japan
726	Site Reference ID/Investigator# 56072	Okinawa	Japan
727	Site Reference ID/Investigator# 56074	Okinawa	Japan
728	Site Reference ID/Investigator# 56075	Okinawa	Japan
729	Site Reference ID/Investigator# 56076	Okinawa	Japan
730	Site Reference ID/Investigator# 56078	Okinawa	Japan
731	Site Reference ID/Investigator# 56080	Okinawa	Japan
732	Site Reference ID/Investigator# 56081	Okinawa	Japan
733	Site Reference ID/Investigator# 60255	Okinawa	Japan
734	Site Reference ID/Investigator# 60268	Okinawa	Japan
735	Site Reference ID/Investigator# 60393	Okinawa	Japan
736	Site Reference ID/Investigator# 60420	Okinawa	Japan
737	Site Reference ID/Investigator# 60548	Okinawa	Japan
738	Site Reference ID/Investigator# 65136	Okinawa	Japan
739	Site Reference ID/Investigator# 65137	Okinawa	Japan
740	Site Reference ID/Investigator# 55819	Ome	Japan
741	Site Reference ID/Investigator# 79899	Omuta	Japan
742	Site Reference ID/Investigator# 79933	Omuta	Japan
743	Site Reference ID/Investigator# 89855	Omuta	Japan
744	Site Reference ID/Investigator# 48705	Osakasayama	Japan
745	Site Reference ID/Investigator# 48700	Osaka	Japan
746	Site Reference ID/Investigator# 48701	Osaka	Japan
747	Site Reference ID/Investigator# 48702	Osaka	Japan
748	Site Reference ID/Investigator# 48703	Osaka	Japan
749	Site Reference ID/Investigator# 48706	Osaka	Japan
750	Site Reference ID/Investigator# 49027	Osaka	Japan
751	Site Reference ID/Investigator# 49029	Osaka	Japan
752	Site Reference ID/Investigator# 49030	Osaka	Japan
753	Site Reference ID/Investigator# 49031	Osaka	Japan
754	Site Reference ID/Investigator# 49033	Osaka	Japan
755	Site Reference ID/Investigator# 49034	Osaka	Japan
756	Site Reference ID/Investigator# 49035	Osaka	Japan
757	Site Reference ID/Investigator# 49036	Osaka	Japan
758	Site Reference ID/Investigator# 49037	Osaka	Japan
759	Site Reference ID/Investigator# 55174	Osaka	Japan
760	Site Reference ID/Investigator# 55321	Osaka	Japan
761	Site Reference ID/Investigator# 55578	Osaka	Japan
762	Site Reference ID/Investigator# 55592	Osaka	Japan
763	Site Reference ID/Investigator# 55649	Osaka	Japan
764	Site Reference ID/Investigator# 55651	Osaka	Japan
765	Site Reference ID/Investigator# 55652	Osaka	Japan
766	Site Reference ID/Investigator# 55653	Osaka	Japan
767	Site Reference ID/Investigator# 55654	Osaka	Japan
768	Site Reference ID/Investigator# 55655	Osaka	Japan
769	Site Reference ID/Investigator# 55656	Osaka	Japan
770	Site Reference ID/Investigator# 55666	Osaka	Japan
771	Site Reference ID/Investigator# 55667	Osaka	Japan
772	Site Reference ID/Investigator# 55668	Osaka	Japan
773	Site Reference ID/Investigator# 55669	Osaka	Japan
774	Site Reference ID/Investigator# 55670	Osaka	Japan
775	Site Reference ID/Investigator# 55671	Osaka	Japan
776	Site Reference ID/Investigator# 55672	Osaka	Japan
777	Site Reference ID/Investigator# 55674	Osaka	Japan
778	Site Reference ID/Investigator# 55675	Osaka	Japan
779	Site Reference ID/Investigator# 55678	Osaka	Japan
780	Site Reference ID/Investigator# 55706	Osaka	Japan
781	Site Reference ID/Investigator# 55712	Osaka	Japan
782	Site Reference ID/Investigator# 55717	Osaka	Japan
783	Site Reference ID/Investigator# 60194	Osaka	Japan
784	Site Reference ID/Investigator# 60204	Osaka	Japan
785	Site Reference ID/Investigator# 60243	Osaka	Japan
786	Site Reference ID/Investigator# 60366	Osaka	Japan
787	Site Reference ID/Investigator# 60383	Osaka	Japan
788	Site Reference ID/Investigator# 60505	Osaka	Japan
789	Site Reference ID/Investigator# 60539	Osaka	Japan
790	Site Reference ID/Investigator# 60544	Osaka	Japan
791	Site Reference ID/Investigator# 60546	Osaka	Japan
792	Site Reference ID/Investigator# 60549	Osaka	Japan
793	Site Reference ID/Investigator# 60565	Osaka	Japan
794	Site Reference ID/Investigator# 65104	Osaka	Japan
795	Site Reference ID/Investigator# 65120	Osaka	Japan
796	Site Reference ID/Investigator# 65121	Osaka	Japan
797	Site Reference ID/Investigator# 67167	Osaka	Japan
798	Site Reference ID/Investigator# 67168	Osaka	Japan
799	Site Reference ID/Investigator# 79913	Osaka	Japan
800	Site Reference ID/Investigator# 89815	Osaka	Japan
801	Site Reference ID/Investigator# 90373	Osaka	Japan
802	Site Reference ID/Investigator# 48986	Osaki	Japan
803	Site Reference ID/Investigator# 60247	Ota-ku, Tokyo	Japan
804	Site Reference ID/Investigator# 49057	Otsu	Japan
805	Site Reference ID/Investigator# 55664	Otsu	Japan
806	Site Reference ID/Investigator# 55985	Otsu	Japan
807	Site Reference ID/Investigator# 60522	Otsu	Japan
808	Site Reference ID/Investigator# 89829	Sabae	Japan
809	Site Reference ID/Investigator# 48679	Sagamihara	Japan
810	Site Reference ID/Investigator# 55840	Sagamihara	Japan
811	Site Reference ID/Investigator# 49085	Saga	Japan
812	Site Reference ID/Investigator# 56045	Saga	Japan
813	Site Reference ID/Investigator# 56046	Saga	Japan
814	Site Reference ID/Investigator# 56047	Saga	Japan
815	Site Reference ID/Investigator# 56049	Saga	Japan
816	Site Reference ID/Investigator# 56050	Saga	Japan
817	Site Reference ID/Investigator# 56051	Saga	Japan
818	Site Reference ID/Investigator# 60396	Saga	Japan
819	Site Reference ID/Investigator# 60503	Saga	Japan
820	Site Reference ID/Investigator# 48673	Saitama	Japan
821	Site Reference ID/Investigator# 48674	Saitama	Japan
822	Site Reference ID/Investigator# 48676	Saitama	Japan
823	Site Reference ID/Investigator# 49014	Saitama	Japan
824	Site Reference ID/Investigator# 55323	Saitama	Japan
825	Site Reference ID/Investigator# 55606	Saitama	Japan
826	Site Reference ID/Investigator# 55833	Saitama	Japan
827	Site Reference ID/Investigator# 55834	Saitama	Japan
828	Site Reference ID/Investigator# 55835	Saitama	Japan
829	Site Reference ID/Investigator# 55836	Saitama	Japan
830	Site Reference ID/Investigator# 55838	Saitama	Japan
831	Site Reference ID/Investigator# 55839	Saitama	Japan
832	Site Reference ID/Investigator# 55845	Saitama	Japan
833	Site Reference ID/Investigator# 55846	Saitama	Japan
834	Site Reference ID/Investigator# 55847	Saitama	Japan
835	Site Reference ID/Investigator# 55848	Saitama	Japan
836	Site Reference ID/Investigator# 55849	Saitama	Japan
837	Site Reference ID/Investigator# 60197	Saitama	Japan
838	Site Reference ID/Investigator# 60419	Saitama	Japan
839	Site Reference ID/Investigator# 60526	Saitama	Japan
840	Site Reference ID/Investigator# 60534	Saitama	Japan
841	Site Reference ID/Investigator# 60541	Saitama	Japan
842	Site Reference ID/Investigator# 65118	Saitama	Japan
843	Site Reference ID/Investigator# 65149	Saitama	Japan
844	Site Reference ID/Investigator# 71472	Saitama	Japan
845	Site Reference ID/Investigator# 80221	Sakaide	Japan
846	Site Reference ID/Investigator# 89861	Sakaide	Japan
847	Site Reference ID/Investigator# 55308	Sakai	Japan
848	Site Reference ID/Investigator# 55676	Sakai	Japan
849	Site Reference ID/Investigator# 55677	Sakai	Japan
850	Site Reference ID/Investigator# 60512	Sakai	Japan
851	Site Reference ID/Investigator# 71469	Sakai	Japan
852	Site Reference ID/Investigator# 48666	Sakura	Japan
853	Site Reference ID/Investigator# 48993	Saku	Japan
854	Site Reference ID/Investigator# 56023	Sanuki	Japan
855	Site Reference ID/Investigator# 47382	Sapporo	Japan
856	Site Reference ID/Investigator# 48642	Sapporo	Japan
857	Site Reference ID/Investigator# 48787	Sapporo	Japan
858	Site Reference ID/Investigator# 48789	Sapporo	Japan
859	Site Reference ID/Investigator# 48790	Sapporo	Japan
860	Site Reference ID/Investigator# 55713	Sapporo	Japan
861	Site Reference ID/Investigator# 55868	Sapporo	Japan
862	Site Reference ID/Investigator# 55879	Sapporo	Japan
863	Site Reference ID/Investigator# 55884	Sapporo	Japan
864	Site Reference ID/Investigator# 79956	Sapporo	Japan
865	Site Reference ID/Investigator# 89816	Sapporo	Japan
866	Site Reference ID/Investigator# 90393	Sapporo	Japan
867	Site Reference ID/Investigator# 92733	Sapporo	Japan
868	Site Reference ID/Investigator# 92734	Sapporo	Japan
869	Site Reference ID/Investigator# 89833	Sasayama	Japan
870	Site Reference ID/Investigator# 48771	Sasebo	Japan
871	Site Reference ID/Investigator# 48982	Sendai	Japan
872	Site Reference ID/Investigator# 55175	Sendai	Japan
873	Site Reference ID/Investigator# 55176	Sendai	Japan
874	Site Reference ID/Investigator# 55919	Sendai	Japan
875	Site Reference ID/Investigator# 79895	Sendai	Japan
876	Site Reference ID/Investigator# 89824	Sendai	Japan
877	Site Reference ID/Investigator# 60516	Setouchi	Japan
878	Site Reference ID/Investigator# 60256	Seto	Japan
879	Site Reference ID/Investigator# 55662	Shiga	Japan
880	Site Reference ID/Investigator# 55982	Shiga	Japan
881	Site Reference ID/Investigator# 55986	Shiga	Japan
882	Site Reference ID/Investigator# 55987	Shiga	Japan
883	Site Reference ID/Investigator# 60200	Shiga	Japan
884	Site Reference ID/Investigator# 60250	Shiga	Japan
885	Site Reference ID/Investigator# 60409	Shiga	Japan
886	Site Reference ID/Investigator# 94895	Shimada	Japan
887	Site Reference ID/Investigator# 55721	Shimane	Japan
888	Site Reference ID/Investigator# 60209	Shimane	Japan
889	Site Reference ID/Investigator# 60218	Shimane	Japan
890	Site Reference ID/Investigator# 65128	Shimane	Japan
891	Site Reference ID/Investigator# 65145	Shimane	Japan
892	Site Reference ID/Investigator# 89830	Shimizu	Japan
893	Site Reference ID/Investigator# 55962	Shimotsuke-shi, Tochigi	Japan
894	Site Reference ID/Investigator# 48687	Shizuoka	Japan
895	Site Reference ID/Investigator# 49009	Shizuoka	Japan
896	Site Reference ID/Investigator# 49012	Shizuoka	Japan
897	Site Reference ID/Investigator# 55579	Shizuoka	Japan
898	Site Reference ID/Investigator# 55589	Shizuoka	Japan
899	Site Reference ID/Investigator# 55609	Shizuoka	Japan
900	Site Reference ID/Investigator# 55610	Shizuoka	Japan
901	Site Reference ID/Investigator# 55611	Shizuoka	Japan
902	Site Reference ID/Investigator# 55881	Shizuoka	Japan
903	Site Reference ID/Investigator# 55883	Shizuoka	Japan
904	Site Reference ID/Investigator# 60212	Shizuoka	Japan
905	Site Reference ID/Investigator# 60374	Shizuoka	Japan
906	Site Reference ID/Investigator# 60400	Shizuoka	Japan
907	Site Reference ID/Investigator# 60406	Shizuoka	Japan
908	Site Reference ID/Investigator# 60418	Shizuoka	Japan
909	Site Reference ID/Investigator# 65153	Shizuoka	Japan
910	Site Reference ID/Investigator# 89821	Shizuoka	Japan
911	Site Reference ID/Investigator# 48753	Shunan	Japan
912	Site Reference ID/Investigator# 55837	Soka	Japan
913	Site Reference ID/Investigator# 89854	Soka	Japan
914	Site Reference ID/Investigator# 55590	Suita	Japan
915	Site Reference ID/Investigator# 60365	Suita	Japan
916	Site Reference ID/Investigator# 68635	Suwa	Japan
917	Site Reference ID/Investigator# 90397	Suzuka	Japan
918	Site Reference ID/Investigator# 48698	Tajimi	Japan
919	Site Reference ID/Investigator# 48756	Takamatsu	Japan
920	Site Reference ID/Investigator# 55173	Takamatsu	Japan
921	Site Reference ID/Investigator# 55172	Takarazuka	Japan
922	Site Reference ID/Investigator# 89862	Takarazuka	Japan
923	Site Reference ID/Investigator# 60372	Takasaki	Japan
924	Site Reference ID/Investigator# 90395	Takasaki	Japan
925	Site Reference ID/Investigator# 49028	Takatsuki	Japan
926	Site Reference ID/Investigator# 55165	Takatsuki	Japan
927	Site Reference ID/Investigator# 55648	Takatsuki	Japan
928	Site Reference ID/Investigator# 55166	Tenri	Japan
929	Site Reference ID/Investigator# 89863	Tenri	Japan
930	Site Reference ID/Investigator# 55659	Tochigi	Japan
931	Site Reference ID/Investigator# 55961	Tochigi	Japan
932	Site Reference ID/Investigator# 60254	Tochigi	Japan
933	Site Reference ID/Investigator# 60265	Tochigi	Japan
934	Site Reference ID/Investigator# 60562	Tochigi	Japan
935	Site Reference ID/Investigator# 67170	Tochigi	Japan
936	Site Reference ID/Investigator# 68643	Tochigi	Japan
937	Site Reference ID/Investigator# 55628	Toki	Japan
938	Site Reference ID/Investigator# 49073	Tokushima	Japan
939	Site Reference ID/Investigator# 55314	Tokushima	Japan
940	Site Reference ID/Investigator# 55580	Tokushima	Japan
941	Site Reference ID/Investigator# 56028	Tokushima	Japan
942	Site Reference ID/Investigator# 56029	Tokushima	Japan
943	Site Reference ID/Investigator# 71465	Tokushima	Japan
944	Site Reference ID/Investigator# 48658	Tokyo	Japan
945	Site Reference ID/Investigator# 48659	Tokyo	Japan
946	Site Reference ID/Investigator# 48660	Tokyo	Japan
947	Site Reference ID/Investigator# 48661	Tokyo	Japan
948	Site Reference ID/Investigator# 48662	Tokyo	Japan
949	Site Reference ID/Investigator# 48663	Tokyo	Japan
950	Site Reference ID/Investigator# 48664	Tokyo	Japan
951	Site Reference ID/Investigator# 48665	Tokyo	Japan
952	Site Reference ID/Investigator# 48783	Tokyo	Japan
953	Site Reference ID/Investigator# 48992	Tokyo	Japan
954	Site Reference ID/Investigator# 48996	Tokyo	Japan
955	Site Reference ID/Investigator# 48997	Tokyo	Japan
956	Site Reference ID/Investigator# 48999	Tokyo	Japan
957	Site Reference ID/Investigator# 49003	Tokyo	Japan
958	Site Reference ID/Investigator# 49004	Tokyo	Japan
959	Site Reference ID/Investigator# 49005	Tokyo	Japan
960	Site Reference ID/Investigator# 49007	Tokyo	Japan
961	Site Reference ID/Investigator# 55168	Tokyo	Japan
962	Site Reference ID/Investigator# 55170	Tokyo	Japan
963	Site Reference ID/Investigator# 55191	Tokyo	Japan
964	Site Reference ID/Investigator# 55306	Tokyo	Japan
965	Site Reference ID/Investigator# 55318	Tokyo	Japan
966	Site Reference ID/Investigator# 55575	Tokyo	Japan
967	Site Reference ID/Investigator# 55576	Tokyo	Japan
968	Site Reference ID/Investigator# 55594	Tokyo	Japan
969	Site Reference ID/Investigator# 55595	Tokyo	Japan
970	Site Reference ID/Investigator# 55598	Tokyo	Japan
971	Site Reference ID/Investigator# 55604	Tokyo	Japan
972	Site Reference ID/Investigator# 55695	Tokyo	Japan
973	Site Reference ID/Investigator# 55698	Tokyo	Japan
974	Site Reference ID/Investigator# 55711	Tokyo	Japan
975	Site Reference ID/Investigator# 55714	Tokyo	Japan
976	Site Reference ID/Investigator# 55722	Tokyo	Japan
977	Site Reference ID/Investigator# 55784	Tokyo	Japan
978	Site Reference ID/Investigator# 55786	Tokyo	Japan
979	Site Reference ID/Investigator# 55787	Tokyo	Japan
980	Site Reference ID/Investigator# 55792	Tokyo	Japan
981	Site Reference ID/Investigator# 55795	Tokyo	Japan
982	Site Reference ID/Investigator# 55799	Tokyo	Japan
983	Site Reference ID/Investigator# 55854	Tokyo	Japan
984	Site Reference ID/Investigator# 55867	Tokyo	Japan
985	Site Reference ID/Investigator# 55925	Tokyo	Japan
986	Site Reference ID/Investigator# 55926	Tokyo	Japan
987	Site Reference ID/Investigator# 55927	Tokyo	Japan
988	Site Reference ID/Investigator# 55928	Tokyo	Japan
989	Site Reference ID/Investigator# 55933	Tokyo	Japan
990	Site Reference ID/Investigator# 55934	Tokyo	Japan
991	Site Reference ID/Investigator# 55935	Tokyo	Japan
992	Site Reference ID/Investigator# 55936	Tokyo	Japan
993	Site Reference ID/Investigator# 55937	Tokyo	Japan
994	Site Reference ID/Investigator# 55938	Tokyo	Japan
995	Site Reference ID/Investigator# 55939	Tokyo	Japan
996	Site Reference ID/Investigator# 55940	Tokyo	Japan
997	Site Reference ID/Investigator# 55941	Tokyo	Japan
998	Site Reference ID/Investigator# 55944	Tokyo	Japan
999	Site Reference ID/Investigator# 55945	Tokyo	Japan
1000	Site Reference ID/Investigator# 60198	Tokyo	Japan
1001	Site Reference ID/Investigator# 60245	Tokyo	Japan
1002	Site Reference ID/Investigator# 60370	Tokyo	Japan
1003	Site Reference ID/Investigator# 60392	Tokyo	Japan
1004	Site Reference ID/Investigator# 60404	Tokyo	Japan
1005	Site Reference ID/Investigator# 60417	Tokyo	Japan
1006	Site Reference ID/Investigator# 60425	Tokyo	Japan
1007	Site Reference ID/Investigator# 60511	Tokyo	Japan
1008	Site Reference ID/Investigator# 60514	Tokyo	Japan
1009	Site Reference ID/Investigator# 60536	Tokyo	Japan
1010	Site Reference ID/Investigator# 60543	Tokyo	Japan
1011	Site Reference ID/Investigator# 60547	Tokyo	Japan
1012	Site Reference ID/Investigator# 65103	Tokyo	Japan
1013	Site Reference ID/Investigator# 65106	Tokyo	Japan
1014	Site Reference ID/Investigator# 65113	Tokyo	Japan
1015	Site Reference ID/Investigator# 65114	Tokyo	Japan
1016	Site Reference ID/Investigator# 65139	Tokyo	Japan
1017	Site Reference ID/Investigator# 65142	Tokyo	Japan
1018	Site Reference ID/Investigator# 68634	Tokyo	Japan
1019	Site Reference ID/Investigator# 68642	Tokyo	Japan
1020	Site Reference ID/Investigator# 71462	Tokyo	Japan
1021	Site Reference ID/Investigator# 71464	Tokyo	Japan
1022	Site Reference ID/Investigator# 80224	Tokyo	Japan
1023	Site Reference ID/Investigator# 84096	Tokyo	Japan
1024	Site Reference ID/Investigator# 89814	Tokyo	Japan
1025	Site Reference ID/Investigator# 89857	Tokyo	Japan
1026	Site Reference ID/Investigator# 89874	Tokyo	Japan
1027	Site Reference ID/Investigator# 48791	Tomakomai	Japan
1028	Site Reference ID/Investigator# 56073	Tomigusuku	Japan
1029	Site Reference ID/Investigator# 48742	Tonami	Japan
1030	Site Reference ID/Investigator# 79934	Tono	Japan
1031	Site Reference ID/Investigator# 49075	Toon	Japan
1032	Site Reference ID/Investigator# 67166	Toshigi	Japan
1033	Site Reference ID/Investigator# 48750	Tottori	Japan
1034	Site Reference ID/Investigator# 55658	Tottori	Japan
1035	Site Reference ID/Investigator# 55993	Tottori	Japan
1036	Site Reference ID/Investigator# 55994	Tottori	Japan
1037	Site Reference ID/Investigator# 55996	Tottori	Japan
1038	Site Reference ID/Investigator# 55999	Tottori	Japan
1039	Site Reference ID/Investigator# 48743	Toyama	Japan
1040	Site Reference ID/Investigator# 49049	Toyama	Japan
1041	Site Reference ID/Investigator# 55171	Toyama	Japan
1042	Site Reference ID/Investigator# 55309	Toyama	Japan
1043	Site Reference ID/Investigator# 55760	Toyama	Japan
1044	Site Reference ID/Investigator# 55762	Toyama	Japan
1045	Site Reference ID/Investigator# 60373	Toyama	Japan
1046	Site Reference ID/Investigator# 60395	Toyama	Japan
1047	Site Reference ID/Investigator# 60405	Toyama	Japan
1048	Site Reference ID/Investigator# 49010	Toyoake	Japan
1049	Site Reference ID/Investigator# 49023	Toyohashi	Japan
1050	Site Reference ID/Investigator# 94888	Toyokawa	Japan
1051	Site Reference ID/Investigator# 55754	Toyooka	Japan
1052	Site Reference ID/Investigator# 89838	Toyooka	Japan
1053	Site Reference ID/Investigator# 48694	Toyota	Japan
1054	Site Reference ID/Investigator# 49018	Toyota	Japan
1055	Site Reference ID/Investigator# 55710	Toyota	Japan
1056	Site Reference ID/Investigator# 65140	Toyota	Japan
1057	Site Reference ID/Investigator# 68640	Tsuchiura	Japan
1058	Site Reference ID/Investigator# 55956	Tsukuba	Japan
1059	Site Reference ID/Investigator# 60397	Tsuruga	Japan
1060	Site Reference ID/Investigator# 89859	Tsuruoka	Japan
1061	Site Reference ID/Investigator# 55630	Tsu	Japan
1062	Site Reference ID/Investigator# 55631	Tsu	Japan
1063	Site Reference ID/Investigator# 89818	Tsu	Japan
1064	Site Reference ID/Investigator# 55777	Uji	Japan
1065	Site Reference ID/Investigator# 55167	Urayasu	Japan
1066	Site Reference ID/Investigator# 89825	Usa	Japan
1067	Site Reference ID/Investigator# 79879	Ushiku	Japan
1068	Site Reference ID/Investigator# 55830	Utsunomiya	Japan
1069	Site Reference ID/Investigator# 94890	Utsunomiya	Japan
1070	Site Reference ID/Investigator# 49045	Wakayama	Japan
1071	Site Reference ID/Investigator# 49050	Wakayama	Japan
1072	Site Reference ID/Investigator# 55686	Wakayama	Japan
1073	Site Reference ID/Investigator# 55687	Wakayama	Japan
1074	Site Reference ID/Investigator# 55688	Wakayama	Japan
1075	Site Reference ID/Investigator# 55689	Wakayama	Japan
1076	Site Reference ID/Investigator# 55690	Wakayama	Japan
1077	Site Reference ID/Investigator# 55696	Wakayama	Japan
1078	Site Reference ID/Investigator# 60371	Wakayama	Japan
1079	Site Reference ID/Investigator# 60391	Wakayama	Japan
1080	Site Reference ID/Investigator# 60525	Wakayama	Japan
1081	Site Reference ID/Investigator# 60551	Wakayama	Japan
1082	Site Reference ID/Investigator# 65123	Wakayama	Japan
1083	Site Reference ID/Investigator# 67155	Wakayama	Japan
1084	Site Reference ID/Investigator# 48670	Yachiyo	Japan
1085	Site Reference ID/Investigator# 55910	Yamagata	Japan
1086	Site Reference ID/Investigator# 55911	Yamagata	Japan
1087	Site Reference ID/Investigator# 55915	Yamagata	Japan
1088	Site Reference ID/Investigator# 55916	Yamagata	Japan
1089	Site Reference ID/Investigator# 60219	Yamagata	Japan
1090	Site Reference ID/Investigator# 60267	Yamagata	Japan
1091	Site Reference ID/Investigator# 60403	Yamagata	Japan
1092	Site Reference ID/Investigator# 65154	Yamagata	Japan
1093	Site Reference ID/Investigator# 94803	Yamagata	Japan
1094	Site Reference ID/Investigator# 48752	Yamaguchi	Japan
1095	Site Reference ID/Investigator# 48754	Yamaguchi	Japan
1096	Site Reference ID/Investigator# 49065	Yamaguchi	Japan
1097	Site Reference ID/Investigator# 49066	Yamaguchi	Japan
1098	Site Reference ID/Investigator# 49067	Yamaguchi	Japan
1099	Site Reference ID/Investigator# 55591	Yamaguchi	Japan
1100	Site Reference ID/Investigator# 55700	Yamaguchi	Japan
1101	Site Reference ID/Investigator# 56009	Yamaguchi	Japan
1102	Site Reference ID/Investigator# 56012	Yamaguchi	Japan
1103	Site Reference ID/Investigator# 56013	Yamaguchi	Japan
1104	Site Reference ID/Investigator# 56015	Yamaguchi	Japan
1105	Site Reference ID/Investigator# 60515	Yamaguchi	Japan
1106	Site Reference ID/Investigator# 94891	Yamatokoriyama	Japan
1107	Site Reference ID/Investigator# 55679	Yamatotakada	Japan
1108	Site Reference ID/Investigator# 79896	Yanagawa	Japan
1109	Site Reference ID/Investigator# 80217	Yanagawa	Japan
1110	Site Reference ID/Investigator# 60202	Yatomi	Japan
1111	Site Reference ID/Investigator# 79874	Yatsushiro	Japan
1112	Site Reference ID/Investigator# 48699	Yokkaichi	Japan
1113	Site Reference ID/Investigator# 48677	Yokohama	Japan
1114	Site Reference ID/Investigator# 48678	Yokohama	Japan
1115	Site Reference ID/Investigator# 55160	Yokohama	Japan
1116	Site Reference ID/Investigator# 55310	Yokohama	Japan
1117	Site Reference ID/Investigator# 55852	Yokohama	Japan
1118	Site Reference ID/Investigator# 55856	Yokohama	Japan
1119	Site Reference ID/Investigator# 55858	Yokohama	Japan
1120	Site Reference ID/Investigator# 60399	Yokohama	Japan
1121	Site Reference ID/Investigator# 60506	Yokohama	Japan
1122	Site Reference ID/Investigator# 65152	Yokohama	Japan
1123	Site Reference ID/Investigator# 79954	Yokohama	Japan
1124	Site Reference ID/Investigator# 89832	Yokohama	Japan
1125	Site Reference ID/Investigator# 90400	Yokohama	Japan
1126	Site Reference ID/Investigator# 60424	Yokosuka	Japan
1127	Site Reference ID/Investigator# 80218	Yokote	Japan
1128	Site Reference ID/Investigator# 49058	Yonago	Japan
1129	Site Reference ID/Investigator# 55709	Yonago	Japan
1130	Site Reference ID/Investigator# 55998	Yonago	Japan
1131	Site Reference ID/Investigator# 56057	Yufu	Japan

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Director: Sadanori Abe, AbbVie GK.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

AbbVie (prior sponsor, Abbott)

ClinicalTrials.gov Identifier:

NCT01298648

Other Study ID Numbers:

P12-706

First Posted:

Feb 18, 2011

Last Update Posted:

Jul 2, 2018

Last Verified:

Mar 1, 2014

Keywords provided by AbbVie (prior sponsor, Abbott)

Crohn's Disease

Additional relevant MeSH terms:

Crohn Disease

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Humira
Arm/Group Description	Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Period Title: Overall Study
STARTED	1716
COMPLETED	1693
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	Humira
Arm/Group Description	Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Overall Participants	1693
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.5 (11.7)
Sex: Female, Male (Count of Participants)
Female	584 34.5%
Male	1109 65.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description
Safety analysis set: Excluding 21 patients who were transferred to other institutions during the surveillance period and 2 patients who made no visit after the first administration, 1693 patients were included in the safety analysis set.

Arm/Group Title	Humira
Arm/Group Description	Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Measure Participants	1693
AEs	453 26.8%
SAEs	147 8.7%
ADRs	360 21.3%
SADRs	96 5.7%

2. Primary Outcome

Title	Crohn's Disease Activity Index (CDAI) at Baseline and Week 4
Description	The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description
Participants with available data at each time point.

Arm/Group Title	Humira
Arm/Group Description	Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Measure Participants	1017
Baseline (n=1017)	204.3 (105.7)
Week 4 (n=912)	142.9 (90.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Humira
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments	Paired t-test using observed cases at Baseline and Week 4.

3. Secondary Outcome

Title	Improvement Rating by Investigator at Week 24
Description	Overall response rating, according to investigator's subjective clinical opinion. The level of improvement (markedly improved, improved, not improved, or not assessable) was categorized by comparing clinical condition at week 24 or at discontinuation with baseline condition.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Humira
Arm/Group Description	Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Measure Participants	1619
Percentage of Participants Markedly improved	20.6 1.2%
Percentage of Participants Improved	55.3 3.3%
Percentage of Participants Not Improved	17.2 1%
Percentage of Participants Not Assessable	7.0 0.4%

4. Primary Outcome

Title	Crohn's Disease Activity Index (CDAI) at Baseline and Week 8
Description	The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description
Participants with available data at each time point.

Arm/Group Title	Humira
Arm/Group Description	Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Measure Participants	1017
Baseline (n=1017)	204.3 (105.7)
Week 8 (n=818)	142.7 (93.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Humira
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments	Paired t-test using observed values at Baseline and Week 8.

5. Primary Outcome

Title	Crohn's Disease Activity Index (CDAI) at Baseline and Week 24
Description	The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
Participants with available data at each time point.

Arm/Group Title	Humira
Arm/Group Description	Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Measure Participants	1017
Baseline (n=1017)	204.3 (105.7)
Week 24 (n=982)	149.1 (100.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Humira
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments	Paired t-test using observed values at Baseline and Week 24.

6. Secondary Outcome

Title	Remission Rate at Week 4, Week 8, and Week 24
Description	The remission rate for each evaluation timepoint (Weeks 4, 8, and 24) was calculated as the number of participants that had CDAI < 150 divided by the number of participants at Baseline that had CDAI scores ≥ 150.
Time Frame	Baseline, Week 4, Week 8, and Week 24

Outcome Measure Data

Analysis Population Description
Participants with available data at each time point.

Arm/Group Title	Humira
Arm/Group Description	Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Measure Participants	1017
Week 4 (284/607)	46.8 2.8%
Week 8 (260/542)	48.0 2.8%
Week 24 (304/649)	46.8 2.8%

Adverse Events

	Humira
Time Frame	24 weeks.
Adverse Event Reporting Description

Arm/Group Title	Humira
Arm/Group Description	Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Humira
	Affected / at Risk (%)	# Events
Total	147/1693 (8.7%)
Blood and lymphatic system disorders
Anaemia	2/1693 (0.1%)
Disseminated intravascular coagulation	2/1693 (0.1%)
Pancytopenia	2/1693 (0.1%)
Cardiac disorders
Bradycardia	1/1693 (0.1%)
Cardiac failure	2/1693 (0.1%)
Cardiovascular disorder	1/1693 (0.1%)
Gastrointestinal disorders
Abdominal pain	2/1693 (0.1%)
Anal stenosis	1/1693 (0.1%)
Anorectal disorder	1/1693 (0.1%)
Ascites	1/1693 (0.1%)
Crohn's disease	13/1693 (0.8%)
Diarrhoea	1/1693 (0.1%)
Frequent bowel movements	1/1693 (0.1%)
Gastrointestinal haemorrhage	2/1693 (0.1%)
Gastrointestinal stenosis	1/1693 (0.1%)
Haemorrhoids	1/1693 (0.1%)
IIleal stenosis	1/1693 (0.1%)
Ileus	4/1693 (0.2%)
Intestinal obstruction	9/1693 (0.5%)
Intestinal perforation	1/1693 (0.1%)
Intestinal stenosis	5/1693 (0.3%)
Large intestine perforation	1/1693 (0.1%)
Melaena	4/1693 (0.2%)
Pancreatitis acute	1/1693 (0.1%)
Rectal ulcer haemorrhage	1/1693 (0.1%)
Small intestinal perforation	2/1693 (0.1%)
Stomatitis	1/1693 (0.1%)
Subileus	7/1693 (0.4%)
Enterocutaneous fistula	1/1693 (0.1%)
Anorectal varices haemorrhage	1/1693 (0.1%)
General disorders
Chest discomfort	1/1693 (0.1%)
Malaise	1/1693 (0.1%)
Multi-organ failure	1/1693 (0.1%)
Pyrexia	4/1693 (0.2%)
Sudden death	1/1693 (0.1%)
Hepatobiliary disorders
Bile duct stone	2/1693 (0.1%)
Cholecystitis	1/1693 (0.1%)
Cholelithiasis	2/1693 (0.1%)
Hepatic cirrhosis	1/1693 (0.1%)
Hepatic failure	1/1693 (0.1%)
Hepatic function abnormal	2/1693 (0.1%)
Infections and infestations
Abdominal wall abscess	1/1693 (0.1%)
Abscess intestinal	1/1693 (0.1%)
Bacteraemia	1/1693 (0.1%)
Cellulitis	1/1693 (0.1%)
Cholangitis suppurative	1/1693 (0.1%)
Clostridium difficile colitis	1/1693 (0.1%)
Hepatitis B	1/1693 (0.1%)
Herpes zoster	3/1693 (0.2%)
Pelvic abscess	1/1693 (0.1%)
Peritonitis	2/1693 (0.1%)
Pneumonia	6/1693 (0.4%)
Postoperative wound infection	1/1693 (0.1%)
Sepsis	4/1693 (0.2%)
Tonsillitis	1/1693 (0.1%)
Tuberculosis	1/1693 (0.1%)
Urinary tract infection	1/1693 (0.1%)
Vestibular neuronitis	1/1693 (0.1%)
Viral infection	1/1693 (0.1%)
Anal abscess	7/1693 (0.4%)
Salpingo-oophoritis	1/1693 (0.1%)
Intestinal fistula infection	1/1693 (0.1%)
Perirectal abscess	1/1693 (0.1%)
Staphylococcal sepsis	1/1693 (0.1%)
Lung infection pseudomonal	1/1693 (0.1%)
Enteritis infectious	1/1693 (0.1%)
Pseudomonal sepsis	1/1693 (0.1%)
Abdominal abscess	4/1693 (0.2%)
Pneumonia bacterial	1/1693 (0.1%)
Chlamydial infection	1/1693 (0.1%)
Clostridial infection	1/1693 (0.1%)
Enterocolitis viral	1/1693 (0.1%)
Herpes ophthalmic	1/1693 (0.1%)
Device related infection	2/1693 (0.1%)
Infectious peritonitis	3/1693 (0.2%)
Injury, poisoning and procedural complications
Administration related reaction	1/1693 (0.1%)
Investigations
Blood creatine phosphokinase increased	2/1693 (0.1%)
Blood pressure increased	1/1693 (0.1%)
Platelet count decreased	1/1693 (0.1%)
Red blood cell count decreased	1/1693 (0.1%)
Weight decreased	1/1693 (0.1%)
White blood cell count decreased	1/1693 (0.1%)
Metabolism and nutrition disorders
Dehydration	1/1693 (0.1%)
Hyperkalaemia	1/1693 (0.1%)
Hypoalbuminaemia	2/1693 (0.1%)
Hypocalcaemia	2/1693 (0.1%)
Hypokalaemia	1/1693 (0.1%)
Hypomagnesaemia	1/1693 (0.1%)
Malnutrition	1/1693 (0.1%)
Hyperamylasaemia	1/1693 (0.1%)
Musculoskeletal and connective tissue disorders
Myalgia	1/1693 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer	1/1693 (0.1%)
Neurilemmoma	1/1693 (0.1%)
Anal cancer	3/1693 (0.2%)
Leukaemia recurrent	1/1693 (0.1%)
Thyroid cancer	1/1693 (0.1%)
Nervous system disorders
Cerebral haemorrhage	1/1693 (0.1%)
Cranial nerve palsies multiple	1/1693 (0.1%)
Headache	1/1693 (0.1%)
Mononeuropathy multiplex	1/1693 (0.1%)
Vasculitis cerebral	1/1693 (0.1%)
Lacunar infarction	1/1693 (0.1%)
Chronic inflammatory demyelinating polyradiculoneuropathy	1/1693 (0.1%)
Psychiatric disorders
Depression	1/1693 (0.1%)
Panic disorder	1/1693 (0.1%)
Adjustment disorder	1/1693 (0.1%)
Renal and urinary disorders
Nephrolithiasis	1/1693 (0.1%)
Renal haemorrhage	1/1693 (0.1%)
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration	1/1693 (0.1%)
Pulmonary artery thrombosis	1/1693 (0.1%)
Respiratory failure	1/1693 (0.1%)
Skin and subcutaneous tissue disorders
Eczema	1/1693 (0.1%)
Rash	2/1693 (0.1%)
Rash erythematous	1/1693 (0.1%)
Vascular disorders
Jugular vein thrombosis	1/1693 (0.1%)
Vena cava thrombosis	1/1693 (0.1%)
Shock haemorrhagic	1/1693 (0.1%)
Deep vein thrombosis	1/1693 (0.1%)
Other (Not Including Serious) Adverse Events
	Humira
	Affected / at Risk (%)	# Events
Total	177/1693 (10.5%)
Blood and lymphatic system disorders
Anaemia	8/1693 (0.5%)
Gastrointestinal disorders
Nausea	9/1693 (0.5%)
General disorders
Injection site erythema	11/1693 (0.6%)
Injection site reactions	24/1693 (1.4%)
Malaise	9/1693 (0.5%)
Pyrexia	22/1693 (1.3%)
Hepatobiliary disorders
Hepatic function abnormal	9/1693 (0.5%)
Liver disorder	11/1693 (0.6%)
Infections and infestations
Bronchitis	10/1693 (0.6%)
Influenza	8/1693 (0.5%)
Nasopharyngitis	30/1693 (1.8%)
Pharyngitis	13/1693 (0.8%)
Nervous system disorders
Headache	9/1693 (0.5%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	13/1693 (0.8%)
Skin and subcutaneous tissue disorders
Rash	24/1693 (1.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

Results Point of Contact

Name/Title	Global Medical Services
Organization	AbbVie (prior sponsor, Abbott)
Phone	800-633-9110
Email

Responsible Party:

AbbVie (prior sponsor, Abbott)

ClinicalTrials.gov Identifier:

NCT01298648

Other Study ID Numbers:

P12-706

First Posted:

Feb 18, 2011

Last Update Posted:

Jul 2, 2018

Last Verified:

Mar 1, 2014

Special Investigation in Patients With Crohn's Disease (All Patients Investigation)

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact