NCT00422383 · ADVERSE EVENTS

Adverse events

A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA) · Source last updated 2015-05-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All adverse events (AEs) were collected from BL to Week 4 of Safety Follow-Up (SFU), after which only serious AEs (SAEs) were collected for the remainder of the SFU. SFU was done 4, 12, 24, 36 and 48 weeks after withdrawal.
Other-event reporting threshold: 5%

The safety analysis group included all randomized participants who received at least 1 infusion of study medication.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Rituximab Low Dose + Methotrexate Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.	15 / 134	120 / 134	Not reported / Not reported
Rituximab Escalated Dose + Methotrexate Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.	21 / 119	103 / 119	Not reported / Not reported
Rituximab High Dose + Methotrexate Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.	16 / 93	88 / 93	Not reported / Not reported
Rituximab/Placebo + Methotrexate Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.	1 / 6	6 / 6	Not reported / Not reported
Rituximab Decreased Dose + Methotrexate Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.	3 / 25	22 / 25	Not reported / Not reported

Group identifiers: EG000: Rituximab Low Dose + Methotrexate · EG001: Rituximab Escalated Dose + Methotrexate · EG002: Rituximab High Dose + Methotrexate · EG003: Rituximab/Placebo + Methotrexate · EG004: Rituximab Decreased Dose + Methotrexate

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
1
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
1
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Diverticulum
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
0
num At Risk
119
group Id
EG002
num Affected
1
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Inguinal hernia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
1
num At Risk
134
group Id
EG001
num Affected
1
num At Risk
119
group Id
EG002
num Affected
1
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Cholelithiasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
1
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Intracranial aneurysm
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
0
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
25
term
Sciatica
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
1
num At Risk
134
group Id
EG001
num Affected
0
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Tremor
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
1
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Ocular vascular disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
1
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Renal colic
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
0
num At Risk
119
group Id
EG002
num Affected
1
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Endometriosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
1
num At Risk
134
group Id
EG001
num Affected
0
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Skin ulcer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
2
num At Risk
134
group Id
EG001
num Affected
5
num At Risk
119
group Id
EG002
num Affected
1
num At Risk
93
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Rheumatoid arthritis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.1)
stats
group Id
EG000
num Affected
39
num At Risk
134
group Id
EG001
num Affected
37
num At Risk
119
group Id
EG002
num Affected
28
num At Risk
93
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
6
num At Risk
25
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
31
num At Risk
134
group Id
EG001
num Affected
25
num At Risk
119
group Id
EG002
num Affected
27
num At Risk
93
group Id
EG003
num Affected
4
num At Risk
6
group Id
EG004
num Affected
7
num At Risk
25
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
26
num At Risk
134
group Id
EG001
num Affected
20
num At Risk
119
group Id
EG002
num Affected
17
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
25
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
23
num At Risk
134
group Id
EG001
num Affected
14
num At Risk
119
group Id
EG002
num Affected
17
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
5
num At Risk
25
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
13
num At Risk
134
group Id
EG001
num Affected
16
num At Risk
119
group Id
EG002
num Affected
17
num At Risk
93
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
25
term
Sinusitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
18
num At Risk
134
group Id
EG001
num Affected
11
num At Risk
119
group Id
EG002
num Affected
12
num At Risk
93
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
25
term
Influenza
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
11
num At Risk
134
group Id
EG001
num Affected
14
num At Risk
119
group Id
EG002
num Affected
13
num At Risk
93
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
3
num At Risk
25
term
Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
8
num At Risk
134
group Id
EG001
num Affected
7
num At Risk
119
group Id
EG002
num Affected
8
num At Risk
93
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
4
num At Risk
25
term
Pharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
8
num At Risk
134
group Id
EG001
num Affected
6
num At Risk
119
group Id
EG002
num Affected
3
num At Risk
93
group Id
EG003
num Affected
3
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
25
term
Lower respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
7
num At Risk
134
group Id
EG001
num Affected
9
num At Risk
119
group Id
EG002
num Affected
5
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Rhinitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
3
num At Risk
134
group Id
EG001
num Affected
11
num At Risk
119
group Id
EG002
num Affected
5
num At Risk
93
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Oral herpes
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
6
num At Risk
134
group Id
EG001
num Affected
7
num At Risk
119
group Id
EG002
num Affected
5
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Cystitis

Complete source fields

description

The safety analysis group included all randomized participants who received at least 1 infusion of study medication.

event Groups

description
Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
id
EG000
other Num Affected
120
other Num At Risk
134
serious Num Affected
15
serious Num At Risk
134
title
Rituximab Low Dose + Methotrexate
description
Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
id
EG001
other Num Affected
103
other Num At Risk
119
serious Num Affected
21
serious Num At Risk
119
title
Rituximab Escalated Dose + Methotrexate
description
Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
id
EG002
other Num Affected
88
other Num At Risk
93
serious Num Affected
16
serious Num At Risk
93
title
Rituximab High Dose + Methotrexate
description
Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Rituximab/Placebo + Methotrexate
description
Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
id
EG004
other Num Affected
22
other Num At Risk
25
serious Num Affected
3
serious Num At Risk
25
title
Rituximab Decreased Dose + Methotrexate

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.1)
stats
group Id
EG000
num Affected
39
num At Risk
134
group Id
EG001
num Affected
37
num At Risk
119
group Id
EG002
num Affected
28
num At Risk
93
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
6
num At Risk
25
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
31
num At Risk
134
group Id
EG001
num Affected
25
num At Risk
119
group Id
EG002
num Affected
27
num At Risk
93
group Id
EG003
num Affected
4
num At Risk
6
group Id
EG004
num Affected
7
num At Risk
25
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
26
num At Risk
134
group Id
EG001
num Affected
20
num At Risk
119
group Id
EG002
num Affected
17
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
25
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
23
num At Risk
134
group Id
EG001
num Affected
14
num At Risk
119
group Id
EG002
num Affected
17
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
5
num At Risk
25
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
13
num At Risk
134
group Id
EG001
num Affected
16
num At Risk
119
group Id
EG002
num Affected
17
num At Risk
93
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
25
term
Sinusitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
18
num At Risk
134
group Id
EG001
num Affected
11
num At Risk
119
group Id
EG002
num Affected
12
num At Risk
93
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
25
term
Influenza
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
11
num At Risk
134
group Id
EG001
num Affected
14
num At Risk
119
group Id
EG002
num Affected
13
num At Risk
93
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
3
num At Risk
25
term
Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
8
num At Risk
134
group Id
EG001
num Affected
7
num At Risk
119
group Id
EG002
num Affected
8
num At Risk
93
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
4
num At Risk
25
term
Pharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
8
num At Risk
134
group Id
EG001
num Affected
6
num At Risk
119
group Id
EG002
num Affected
3
num At Risk
93
group Id
EG003
num Affected
3
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
25
term
Lower respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
7
num At Risk
134
group Id
EG001
num Affected
9
num At Risk
119
group Id
EG002
num Affected
5
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Rhinitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
3
num At Risk
134
group Id
EG001
num Affected
11
num At Risk
119
group Id
EG002
num Affected
5
num At Risk
93
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Oral herpes
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
6
num At Risk
134
group Id
EG001
num Affected
7
num At Risk
119
group Id
EG002
num Affected
5
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Cystitis

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
1
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
1
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Diverticulum
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
0
num At Risk
119
group Id
EG002
num Affected
1
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Inguinal hernia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
1
num At Risk
134
group Id
EG001
num Affected
1
num At Risk
119
group Id
EG002
num Affected
1
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Cholelithiasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
1
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Intracranial aneurysm
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
0
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
25
term
Sciatica
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
1
num At Risk
134
group Id
EG001
num Affected
0
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Tremor
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
1
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Ocular vascular disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
1
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Renal colic
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
0
num At Risk
134
group Id
EG001
num Affected
0
num At Risk
119
group Id
EG002
num Affected
1
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Endometriosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
1
num At Risk
134
group Id
EG001
num Affected
0
num At Risk
119
group Id
EG002
num Affected
0
num At Risk
93
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Skin ulcer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (15.1)
stats
group Id
EG000
num Affected
2
num At Risk
134
group Id
EG001
num Affected
5
num At Risk
119
group Id
EG002
num Affected
1
num At Risk
93
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
25
term
Rheumatoid arthritis

time Frame

All adverse events (AEs) were collected from BL to Week 4 of Safety Follow-Up (SFU), after which only serious AEs (SAEs) were collected for the remainder of the SFU. SFU was done 4, 12, 24, 36 and 48 weeks after withdrawal.

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Preserved source evidence · Not medical advice