Trial Outcomes & Findings for Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer (NCT NCT02448810)

Last Updated: 2021-05-25

Results Overview

PFS was defined as time between treatment initiation and tumor progression (per Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1 criteria) or death from any cause, with censoring of participants who were lost to follow-up or withdrew consent.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

115 participants

Primary outcome timeframe

From start of the study up to safety follow-up visit occurred (30 [-/+7]) days after the last dose of study treatment or until disease progression

Results posted on

2021-05-25

Participant Flow

The study was conducted at 21 centers in the United States, the United Kingdom and Spain between 15 June 2015 (first participant first visit) and 15 February 2017 (last participant last visit).

Overall (part 1 and 2) 115 participants were screened, 85 participants were randomized and 79 participants were treated. In part 1, 17 participants were screened, 5 failed screening, 12 were randomized and treated. In part 2, 98 participants were screened, 17 failed screening and 8 did not start the study, 73 were randomized and 67 were treated.

Participant milestones

Participant milestones
Measure	Part 1: Imalumab 7.5 mg/kg + 5-FU/LV Participants with mutated tumors (mutated kirsten rat sarcoma viral oncogene homolog, mutated neuroblastoma rat sarcoma viral oncogene homolog \[KRAS mut, NRAS mut\]) received 7.5 milligram per kilogram (mg/kg) dose of imalumab every week (QW) in combination with 5-fluorouracil/leucovorin (\[FU/LV\] LV 400 milligram per square meter \[mg/m\^2\] intravenous (IV) infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for every 2 weeks (Q2W) IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab Participants with wild-type tumors (wild type Kirsten rat sarcoma viral oncogene homolog, wild neuroblastoma rat sarcoma viral oncogene homolog \[KRAS wt, NRAS wt\]) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + 5-FU/LV Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Overall Study STARTED	3	3	3	3	31	16	18	8
Overall Study Treated	3	3	3	3	29	13	18	7
Overall Study COMPLETED	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	3	3	3	31	16	18	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Imalumab 7.5 mg/kg + 5-FU/LV Participants with mutated tumors (mutated kirsten rat sarcoma viral oncogene homolog, mutated neuroblastoma rat sarcoma viral oncogene homolog \[KRAS mut, NRAS mut\]) received 7.5 milligram per kilogram (mg/kg) dose of imalumab every week (QW) in combination with 5-fluorouracil/leucovorin (\[FU/LV\] LV 400 milligram per square meter \[mg/m\^2\] intravenous (IV) infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for every 2 weeks (Q2W) IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab Participants with wild-type tumors (wild type Kirsten rat sarcoma viral oncogene homolog, wild neuroblastoma rat sarcoma viral oncogene homolog \[KRAS wt, NRAS wt\]) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + 5-FU/LV Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Overall Study Adverse Event	0	0	1	0	0	0	0	0
Overall Study Withdrawal by Subject	0	0	1	0	3	5	0	2
Overall Study Other (study terminated by sponsor)	0	0	0	0	4	2	2	1
Overall Study Death	1	0	1	0	1	0	0	0
Overall Study Other (Progressive disease)	2	2	0	3	23	9	14	5
Overall Study Lost to Follow-up	0	1	0	0	0	0	0	0
Overall Study Other (unspecified)	0	0	0	0	0	0	2	0

Baseline Characteristics

Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Imalumab 7.5 mg/kg + 5-FU/LV n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + 5-FU/LV n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV n=31 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant n=16 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab n=18 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type n=8 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Total n=85 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	21 Participants n=21 Participants	12 Participants n=8 Participants	13 Participants n=8 Participants	5 Participants n=24 Participants	57 Participants n=42 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants	4 Participants n=8 Participants	5 Participants n=8 Participants	3 Participants n=24 Participants	28 Participants n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	13 Participants n=21 Participants	5 Participants n=8 Participants	7 Participants n=8 Participants	6 Participants n=24 Participants	33 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	18 Participants n=21 Participants	11 Participants n=8 Participants	11 Participants n=8 Participants	2 Participants n=24 Participants	52 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	0 Participants n=24 Participants	12 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	26 Participants n=21 Participants	14 Participants n=8 Participants	15 Participants n=8 Participants	8 Participants n=24 Participants	73 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	7 Participants n=42 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	26 Participants n=21 Participants	14 Participants n=8 Participants	18 Participants n=8 Participants	6 Participants n=24 Participants	74 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: From start of the study up to safety follow-up visit occurred (30 [-/+7]) days after the last dose of study treatment or until disease progression

Population: Full analysis set (FAS) included all participants who received at least 1 administration of study drug, and who had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.

Outcome measures

Outcome measures
Measure	Part 1: Imalumab 10 mg/kg + 5-FU/LV n=18 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab n=7 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) n=29 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab n=12 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Part 2: Progression-Free Survival (PFS)	9.3 weeks Interval 8.1 to 24.9	7.3 weeks Interval 3.7 to Upper limit was not available.	11.1 weeks Interval 8.4 to 16.1	8.3 weeks Interval 7.4 to 23.3	—	—	—	—

PRIMARY outcome

Timeframe: From start of study treatment up to 28 days

Population: SAS included all participants who received at least 1 administration of study drug.

DLT was defined as any drug-related treatment-emergent adverse event (TEAE) (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v4.03) that occurs during the first 28 days after treatment start and that meets any of the following criteria: i) Any \>= Grade 3 non-hematologic toxicity (excluding: mucositis/stomatitis of Grade 3; diarrhea of \<3 days duration; nausea and vomiting \<3 days duration; fatigue of \<7 days duration; alopecia; single laboratory value out of the normal range that has no clinical significance and that resolves to \<= Grade 2 with adequate measures within 7 days) ii) Any Grade 4 hematologic toxicity (excluding: grade 4 neutropenia lasting for \<= 5 days; isolated grade 4 lymphocytopenia) iii) Grade 3 febrile neutropenia iv) Grade 3 thrombocytopenia associated with bleeding v) Any life-threatening complication or abnormality not covered in NCI CTCAEv4.03.

Outcome measures

Outcome measures
Measure	Part 1: Imalumab 10 mg/kg + 5-FU/LV n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Part 1: Number of Participants With Occurrence of Dose Limiting Toxicity (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From start of study drug administration up to end of treatment (EOT) (approximately 21 Months)

Population: SAS included all participants who received at least 1 administration of study drug.

Number of participants with occurrence of binding and/or neutralizing anti-imalumab antibodies were reported.

Outcome measures

Outcome measures
Measure	Part 1: Imalumab 10 mg/kg + 5-FU/LV n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV n=29 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant n=13 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab n=18 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type n=7 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies Baseline (Binding antibody)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies End of Study (Binding antibody)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies Baseline (Neutralizing antibody)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies End of Study (Neutralizing antibody)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From start of study drug administration up to EOT (approximately 21 Months)

Population: SAS included all participants who received at least 1 administration of study drug.

Infusion reaction was defined as any relevant sign or symptom occurring during or after imalumab infusion and considered by the investigator as an infusion reaction.

Outcome measures

Outcome measures
Measure	Part 1: Imalumab 10 mg/kg + 5-FU/LV n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV n=29 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant n=13 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab n=18 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type n=7 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Number of Participants With Incidence of Infusion Reactions After Imalumab Administration	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From start of study drug administration up to EOT (approximately 21 Months)

Population: SAS included all participants who received at least 1 administration of study drug.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement. TEAEs was defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.

Outcome measures

Outcome measures
Measure	Part 1: Imalumab 10 mg/kg + 5-FU/LV n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV n=29 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant n=13 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab n=18 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type n=7 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) SAEs	1 Participants	2 Participants	1 Participants	1 Participants	15 Participants	8 Participants	7 Participants	2 Participants
Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) TEAEs	3 Participants	3 Participants	3 Participants	3 Participants	28 Participants	13 Participants	17 Participants	7 Participants

SECONDARY outcome

Timeframe: Day 28 of Cycle 2 followed by every 2 Cycles of 28 day Cycles: Day 56, Day 112, Day 168 and Day 224

Population: FAS included all participants who received at least 1 administration of study drug, and had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.

Number of participants with response evaluation according to RECIST v1.1 was evaluated according to complete response (CR): disappearance of all target and non-target lesions and no new lesions; partial response (PR): \>= 30 percent (%) decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; stable disease (SD): neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; progressive disease (PD): \>= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of \>=5 millimeter (mm) (compared to the previous minimum sum) or progression of a new lesion.

Outcome measures

Outcome measures
Measure	Part 1: Imalumab 10 mg/kg + 5-FU/LV n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV n=29 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant n=12 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab n=18 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type n=7 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Best Overall Response: Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Best Overall Response: Partial Response (PR)	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Best Overall Response: Stable Disease (SD)	2 Participants	1 Participants	1 Participants	1 Participants	14 Participants	4 Participants	6 Participants	2 Participants
Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Best Overall Response: Progressive Disease (PD)	1 Participants	2 Participants	2 Participants	0 Participants	15 Participants	7 Participants	8 Participants	4 Participants
Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Best Overall Response: Not Evaluable (NE)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From start of study drug administration up to EOT (approximately 21 Months)

Overall survival was defined as the time from randomization until death due to any cause. Here, number of participants analyzed was based on the number of participants who underwent death.

Outcome measures

Outcome measures
Measure	Part 1: Imalumab 10 mg/kg + 5-FU/LV n=2 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV n=16 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant n=10 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab n=8 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Overall Survival	42.7 weeks Interval 16.9 to 42.7	24.9 weeks Interval 9.4 to 42.1	24.9 weeks Interval 7.4 to 40.4	42.7 weeks Interval 15.4 to 77.4	31.9 weeks Interval 26.3 to 58.0	27.2 weeks Interval 9.3 to 46.7	31.4 weeks Interval 19.9 to The median and 95% confidence interval was not available due to insufficient number of events at the end of the study.	NA weeks The median and 95% confidence interval was not available due to insufficient number of events at the end of the study.

SECONDARY outcome

Timeframe: Baseline, 21 Months (EOT) up to follow-up

Population: SAS included all participants who received at least 1 administration of study drug.

EORTC QLQ-C30 was a validated instrument used to measure QoL and assess symptoms and side effects of treatment and the impact on everyday life.The QLQ-C30 was composed of: A) 5 multi-item functioning scales(physical, role, social, emotional and cognitive), that were answered on a 4-point scale (1=Not at all,2=A Little,3=Quite a Bit,4=Very Much). Each score range from 0 to 100 with a higher score representing a higher level of functioning and a better QoL. B) A global health status/QoL scale that was answered on a 7-point scale (1=Very Poor to 7=Excellent). Each score range from 0 to 100 with a higher score representing a better QoL. C) 9 symptom scales(fatigue, nausea/vomiting,pain,financial impact/difficulties,appetite loss,diarrhea, constipation,sleep disturbance/insomnia and dyspnea), that were answered on a 4-point scale (1=Not at all,2=A Little,3=Quite a Bit,4=Very Much). Each score range from 0 to 100 with a higher score representing a greater degree of symptoms and a worse QoL.

Outcome measures

Outcome measures
Measure	Part 1: Imalumab 10 mg/kg + 5-FU/LV n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) n=3 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab n=3 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV n=29 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant n=13 Participants Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab n=18 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type n=7 Participants Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Baseline)	75 score on a scale Standard Deviation 8.330	66.67 score on a scale Standard Deviation 16.665	33.33 score on a scale Standard Deviation 16.665	66.7 score on a scale Standard Deviation 8.335	68.10 score on a scale Standard Deviation 18.510	62.18 score on a scale Standard Deviation 25.371	66.18 score on a scale Standard Deviation 22.529	59.52 score on a scale Standard Deviation 19.501
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (change from baseline (CFB))	-5.56 score on a scale Standard Deviation 4.812	-16.67 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	8.33 score on a scale Standard Deviation 35.355	—	-13.16 score on a scale Standard Deviation 23.293	-13.54 score on a scale Standard Deviation 21.333	-10.42 score on a scale Standard Deviation 17.810	-11.67 score on a scale Standard Deviation 9.502
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Physical functioning scale (Baseline)	88.89 score on a scale Standard Deviation 7.696	80 score on a scale Standard Deviation 6.670	63.33 score on a scale Standard Deviation 26.031	75.56 score on a scale Standard Deviation 19.249	78.45 score on a scale Standard Deviation 18.670	81.15 score on a scale Standard Deviation 15.537	78.89 score on a scale Standard Deviation 20.612	70 score on a scale Standard Deviation 17.950
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Physical functioning scale (CFB)	-2.22 score on a scale Standard Deviation 7.699	-20 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	0 score on a scale Standard Deviation 0	—	-5 score on a scale Standard Deviation 17.198	-21.04 score on a scale Standard Deviation 23.489	-4.10 score on a scale Standard Deviation 10.379	-14.67 score on a scale Standard Deviation 15.918
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Role functioning scale (Baseline)	72.22 score on a scale Standard Deviation 9.619	77.78 score on a scale Standard Deviation 19.243	50 score on a scale Standard Deviation 50	88.89 score on a scale Standard Deviation 19.243	74.41 score on a scale Standard Deviation 24.630	73.08 score on a scale Standard Deviation 30.076	76.85 score on a scale Standard Deviation 19.078	66.67 score on a scale Standard Deviation 25.459
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Role functioning scale (CFB)	-16.67 score on a scale Standard Deviation 16.670	0 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	-25 score on a scale Standard Deviation 35.355	—	-12.04 score on a scale Standard Deviation 24.122	-16.67 score on a scale Standard Deviation 43.642	-11.54 score on a scale Standard Deviation 29.957	-10 score on a scale Standard Deviation 14.910
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Emotional functioning scale (Baseline)	91.67 score on a scale Standard Deviation 8.335	83.33 score on a scale Standard Deviation 16.665	79.67 score on a scale Standard Deviation 26.274	97.22 score on a scale Standard Deviation 4.809	78.87 score on a scale Standard Deviation 18.494	73.08 score on a scale Standard Deviation 25.720	77.45 score on a scale Standard Deviation 19.490	66.66 score on a scale Standard Deviation 18.003
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Emotional functioning scale (CFB)	-5.56 score on a scale Standard Deviation 17.346	-41.66 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	-7 score on a scale Standard Deviation 13.675	—	-3.24 score on a scale Standard Deviation 15.163	-1.04 score on a scale Standard Deviation 16.925	-2.78 score on a scale Standard Deviation 16.792	-11.66 score on a scale Standard Deviation 20.916
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Cognitive functioning scale (Baseline)	100 score on a scale Standard Deviation 0	83.33 score on a scale Standard Deviation 16.665	83.33 score on a scale Standard Deviation 16.665	88.89 score on a scale Standard Deviation 19.243	88.10 score on a scale Standard Deviation 18.063	89.74 score on a scale Standard Deviation 14.496	93.14 score on a scale Standard Deviation 10.306	83.33 score on a scale Standard Deviation 23.571
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Cognitive functioning scale (CFB)	0 score on a scale Standard Deviation 0	-33.33 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	0 score on a scale Standard Deviation 0	—	-1.85 score on a scale Standard Deviation 15.003	-27.08 score on a scale Standard Deviation 30.779	-8.33 score on a scale Standard Deviation 15.075	-6.67 score on a scale Standard Deviation 9.128
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Social functioning scale (Baseline)	77.78 score on a scale Standard Deviation 9.619	77.78 score on a scale Standard Deviation 9.619	77.78 score on a scale Standard Deviation 25.458	66.67 score on a scale Standard Deviation 0	88.69 score on a scale Standard Deviation 15.080	80.77 score on a scale Standard Deviation 24.387	73.53 score on a scale Standard Deviation 29.498	66.67 score on a scale Standard Deviation 27.215
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Social functioning scale (CFB)	-22.22 score on a scale Standard Deviation 9.630	-33.34 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	-8.34 score on a scale Standard Deviation 11.787	—	-13.89 score on a scale Standard Deviation 25.726	-25 score on a scale Standard Deviation 15.430	0 score on a scale Standard Deviation 38.924	-10 score on a scale Standard Deviation 19.004
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue symptom scale (Baseline)	22.33 score on a scale Standard Deviation 0	26 score on a scale Standard Deviation 6.351	29.67 score on a scale Standard Deviation 28.015	29.66 score on a scale Standard Deviation 6.351	33.74 score on a scale Standard Deviation 20.645	38.46 score on a scale Standard Deviation 28.580	29.63 score on a scale Standard Deviation 19.041	41.24 score on a scale Standard Deviation 21.943
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue symptom scale (CFB)	29.45 score on a scale Standard Deviation 23.089	44.34 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	44.50 score on a scale Standard Deviation 15.797	—	9.28 score on a scale Standard Deviation 19.828	23.63 score on a scale Standard Deviation 19.197	3.44 score on a scale Standard Deviation 21.919	13.33 score on a scale Standard Deviation 18.209
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Nausea/vomiting symptom scale (Baseline)	5.56 score on a scale Standard Deviation 9.624	16.67 score on a scale Standard Deviation 16.665	11.11 score on a scale Standard Deviation 19.243	0 score on a scale Standard Deviation 0	13.10 score on a scale Standard Deviation 22.843	6.41 score on a scale Standard Deviation 10.841	7.41 score on a scale Standard Deviation 11.746	4.76 score on a scale Standard Deviation 8.134
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Nausea/vomiting symptom scale (CFB)	5.55 score on a scale Standard Deviation 9.619	-16.66 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	25 score on a scale Standard Deviation 11.780	—	2.78 score on a scale Standard Deviation 24.421	14.58 score on a scale Standard Deviation 20.773	5.13 score on a scale Standard Deviation 30.720	10 score on a scale Standard Deviation 14.906
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Pain symptom scale (Baseline)	16.67 score on a scale Standard Deviation 16.665	38.89 score on a scale Standard Deviation 19.243	38.89 score on a scale Standard Deviation 38.486	27.78 score on a scale Standard Deviation 9.619	31.55 score on a scale Standard Deviation 27.719	23.08 score on a scale Standard Deviation 30.074	22.22 score on a scale Standard Deviation 17.149	35.71 score on a scale Standard Deviation 29.546
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Pain symptom scale (CFB)	11.11 score on a scale Standard Deviation 19.243	0 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	41.66 score on a scale Standard Deviation 35.355	—	5.55 score on a scale Standard Deviation 21.390	12.50 score on a scale Standard Deviation 21.362	6.41 score on a scale Standard Deviation 19.882	13.33 score on a scale Standard Deviation 18.258
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Dyspnea symptom scale (Baseline)	0 score on a scale Standard Deviation 0	22.22 score on a scale Standard Deviation 19.243	11.11 score on a scale Standard Deviation 19.243	11.11 score on a scale Standard Deviation 19.243	11.90 score on a scale Standard Deviation 20.716	20.51 score on a scale Standard Deviation 25.599	14.81 score on a scale Standard Deviation 26.127	9.52 score on a scale Standard Deviation 16.263
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Dyspnea symptom scale (CFB)	11.11 score on a scale Standard Deviation 19.243	33.33 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	33.34 score on a scale Standard Deviation 47.143	—	5.56 score on a scale Standard Deviation 20.612	16.67 score on a scale Standard Deviation 30.861	17.95 score on a scale Standard Deviation 17.296	6.67 score on a scale Standard Deviation 27.886
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sleep disturbance/insomnia symptom scale(Baseline)	33.33 score on a scale Standard Deviation 0	22.22 score on a scale Standard Deviation 19.243	44.45 score on a scale Standard Deviation 38.492	0 score on a scale Standard Deviation 0	23.46 score on a scale Standard Deviation 28.964	20.51 score on a scale Standard Deviation 25.599	22.22 score on a scale Standard Deviation 25.566	47.62 score on a scale Standard Deviation 42.415
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sleep disturbance/insomnia symptom scale (CFB)	33.34 score on a scale Standard Deviation 33.335	0 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	-0.01 score on a scale Standard Deviation 47.143	—	7.84 score on a scale Standard Deviation 34.421	12.50 score on a scale Standard Deviation 30.537	7.69 score on a scale Standard Deviation 14.616	-6.67 score on a scale Standard Deviation 27.886
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Appetite loss symptom scale (Baseline)	11.11 score on a scale Standard Deviation 19.243	22.22 score on a scale Standard Deviation 19.243	11.11 score on a scale Standard Deviation 19.243	22.22 score on a scale Standard Deviation 38.492	25 score on a scale Standard Deviation 33.488	33.33 score on a scale Standard Deviation 38.490	12.96 score on a scale Standard Deviation 20.256	14.28 score on a scale Standard Deviation 17.816
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Appetite loss symptom scale (CFB)	33.33 score on a scale Standard Deviation 33.335	66.67 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	66.67 score on a scale Standard Deviation 0	—	9.26 score on a scale Standard Deviation 29.826	4.17 score on a scale Standard Deviation 27.820	7.69 score on a scale Standard Deviation 24.165	20 score on a scale Standard Deviation 29.816
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Constipation symptom scale (Baseline)	0 score on a scale Standard Deviation 0	22.22 score on a scale Standard Deviation 19.243	11.11 score on a scale Standard Deviation 19.243	22.22 score on a scale Standard Deviation 19.243	17.24 score on a scale Standard Deviation 26.157	25.64 score on a scale Standard Deviation 30.895	22.22 score on a scale Standard Deviation 28.005	19.05 score on a scale Standard Deviation 26.227
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Constipation symptom scale (CFB)	22.22 score on a scale Standard Deviation 38.492	0 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	0 score on a scale Standard Deviation 0	—	7.41 score on a scale Standard Deviation 33.442	16.67 score on a scale Standard Deviation 43.645	2.56 score on a scale Standard Deviation 34.591	6.67 score on a scale Standard Deviation 27.886
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Diarrhea symptom scale (Baseline)	22.22 score on a scale Standard Deviation 19.243	11.11 score on a scale Standard Deviation 19.243	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0	10.34 score on a scale Standard Deviation 18.046	20.51 score on a scale Standard Deviation 34.798	17.65 score on a scale Standard Deviation 26.660	23.81 score on a scale Standard Deviation 25.198
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Diarrhea symptom scale (CFB)	11.11 score on a scale Standard Deviation 19.243	-33.33 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	33.33 score on a scale Standard Deviation 0	—	8.77 score on a scale Standard Deviation 33.040	8.33 score on a scale Standard Deviation 38.834	-11.11 score on a scale Standard Deviation 16.411	0 score on a scale Standard Deviation 23.568
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Financial impact symptom scale (Baseline)	44.44 score on a scale Standard Deviation 50.918	44.44 score on a scale Standard Deviation 19.249	11.11 score on a scale Standard Deviation 19.243	11.11 score on a scale Standard Deviation 19.243	18.39 score on a scale Standard Deviation 30.324	25.64 score on a scale Standard Deviation 33.758	19.61 score on a scale Standard Deviation 23.743	28.57 score on a scale Standard Deviation 23.003
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Financial impact symptom scale (CFB)	-11.11 score on a scale Standard Deviation 19.243	0 score on a scale Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants.	16.67 score on a scale Standard Deviation 23.568	—	-1.75 score on a scale Standard Deviation 25.996	-12.50 score on a scale Standard Deviation 24.801	-5.56 score on a scale Standard Deviation 12.976	20 score on a scale Standard Deviation 18.259

Adverse Events

Part 1: Imalumab 7.5 mg/kg + 5-FU/LV

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Part 1: Imalumab 7.5 mg/kg + Panitumumab

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: Imalumab 10 mg/kg + 5-FU/LV

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: Imalumab 10 mg/kg + Panitumumab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: Imalumab 10 mg/kg + 5-FU/LV

Serious events: 15 serious events

Other events: 28 other events

Deaths: 10 deaths

Part 2: Standard of Care Mutant

Serious events: 8 serious events

Other events: 12 other events

Deaths: 7 deaths

Part 2: Imalumab 10 mg/kg + Panitumumab

Serious events: 7 serious events

Other events: 17 other events

Deaths: 4 deaths

Part 2: Standard of Care Wild Type

Serious events: 2 serious events

Other events: 7 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Imalumab 7.5 mg/kg + 5-FU/LV n=3 participants at risk Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab n=3 participants at risk Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + 5-FU/LV n=3 participants at risk Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab n=3 participants at risk Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV n=29 participants at risk Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant n=13 participants at risk Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab n=18 participants at risk Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type n=7 participants at risk Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	6.9% 2/29 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	11.1% 2/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Nervous system disorders Hepatic encephalopathy	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Ascites	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Intestinal obstruction	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Disease progression	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	27.6% 8/29 • Number of events 8 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	23.1% 3/13 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Multiple organ dysfunction syndrome	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders General physical health deterioration	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Pyrexia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Infections and infestations Perineal abscess	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Infections and infestations Rectal abscess	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Nervous system disorders Syncope	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Investigations Blood bilirubin increased	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Hepatobiliary disorders Gallbladder pain	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.

Other adverse events

Other adverse events
Measure	Part 1: Imalumab 7.5 mg/kg + 5-FU/LV n=3 participants at risk Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 7.5 mg/kg + Panitumumab n=3 participants at risk Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + 5-FU/LV n=3 participants at risk Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 1: Imalumab 10 mg/kg + Panitumumab n=3 participants at risk Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + 5-FU/LV n=29 participants at risk Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Mutant n=13 participants at risk Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Imalumab 10 mg/kg + Panitumumab n=18 participants at risk Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.	Part 2: Standard of Care Wild Type n=7 participants at risk Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Infections and infestations Conjunctivitis	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	17.2% 5/29 • Number of events 11 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	23.1% 3/13 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 4 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	13.8% 4/29 • Number of events 6 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	23.1% 3/13 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Cardiac disorders Tachycardia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	10.3% 3/29 • Number of events 4 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	6.9% 2/29 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Vascular disorders Hot flush	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Vascular disorders Hypertension	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 6 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Eye disorders Blepharitis	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Eye disorders Dry eye	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	11.1% 2/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Eye disorders Episcleritis	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Eye disorders Lacrimation increased	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	11.1% 2/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	24.1% 7/29 • Number of events 8 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	30.8% 4/13 • Number of events 4 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	42.9% 3/7 • Number of events 4 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	11.1% 2/18 • Number of events 4 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Abdominal rigidity	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Constipation	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	31.0% 9/29 • Number of events 9 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	30.8% 4/13 • Number of events 4 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	16.7% 3/18 • Number of events 7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	27.6% 8/29 • Number of events 10 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	38.5% 5/13 • Number of events 11 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	27.8% 5/18 • Number of events 6 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	10.3% 3/29 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Flatulence	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Nausea	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	31.0% 9/29 • Number of events 13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	38.5% 5/13 • Number of events 7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	22.2% 4/18 • Number of events 9 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	13.8% 4/29 • Number of events 8 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Tongue ulceration	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	27.6% 8/29 • Number of events 9 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	11.1% 2/18 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Asthenia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	20.7% 6/29 • Number of events 13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	23.1% 3/13 • Number of events 5 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Chest pain	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	6.9% 2/29 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Chills	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	6.9% 2/29 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Early satiety	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Fatigue	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	55.2% 16/29 • Number of events 28 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	30.8% 4/13 • Number of events 11 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	27.8% 5/18 • Number of events 6 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	71.4% 5/7 • Number of events 8 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Hypothermia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Inflammation	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Localised oedema	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Malaise	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Mucosal inflammation	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	31.0% 9/29 • Number of events 18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Oedema peripheral	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	10.3% 3/29 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Pyrexia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	6.9% 2/29 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
General disorders Temperature intolerance	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Infections and infestations Genital herpes	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Infections and infestations Herpes zoster	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Infections and infestations Localised infection	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Infections and infestations Lymph gland infection	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Infections and infestations Oral herpes	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Infections and infestations Paronychia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	22.2% 4/18 • Number of events 6 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Infections and infestations Rash pustular	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Infections and infestations Urinary tract infection	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Injury, poisoning and procedural complications Laceration	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Injury, poisoning and procedural complications Scratch	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Injury, poisoning and procedural complications Venomous sting	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 8 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	6.9% 2/29 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 6 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Investigations Blood albumin increased	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Investigations Blood bilirubin increased	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	6.9% 2/29 • Number of events 4 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Investigations Blood creatinine increased	33.3% 1/3 • Number of events 4 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Investigations Lymphocyte count decreased	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Investigations Neutrophil count decreased	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	23.1% 3/13 • Number of events 16 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Investigations Platelet count decreased	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Investigations Weight decreased	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	66.7% 2/3 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Investigations White blood cell count decreased	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Renal and urinary disorders Chromaturia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Renal and urinary disorders Dysuria	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Renal and urinary disorders Haematuria	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Renal and urinary disorders Micturition urgency	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Renal and urinary disorders Proteinuria	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Renal and urinary disorders Urinary retention	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	20.7% 6/29 • Number of events 10 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	38.5% 5/13 • Number of events 6 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	11.1% 2/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	28.6% 2/7 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	15.4% 2/13 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	11.1% 2/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	16.7% 3/18 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Nervous system disorders Dizziness	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Nervous system disorders Headache	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	11.1% 2/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Nervous system disorders Migraine	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Nervous system disorders Neuralgia	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Nervous system disorders Paraesthesia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 6 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Nervous system disorders Parosmia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Nervous system disorders Restless legs syndrome	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Nervous system disorders Somnolence	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Psychiatric disorders Anxiety	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	11.1% 2/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Psychiatric disorders Depression	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	6.9% 2/29 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	11.1% 2/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Psychiatric disorders Insomnia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	6.9% 2/29 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Reproductive system and breast disorders Menorrhagia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Reproductive system and breast disorders Prostatitis	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Reproductive system and breast disorders Scrotal disorder	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Reproductive system and breast disorders Sexual dysfunction	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	6.9% 2/29 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	16.7% 3/18 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	13.8% 4/29 • Number of events 5 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	16.7% 3/18 • Number of events 4 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	6.9% 2/29 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	11.1% 2/18 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Respiratory, thoracic and mediastinal disorders Upper-Airway cough syndrome	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	44.4% 8/18 • Number of events 22 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	28.6% 2/7 • Number of events 4 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 6/18 • Number of events 6 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Nail discomfort	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 2 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Palmar-Plantar erythrodysaesthesia syndrome	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	7.7% 1/13 • Number of events 4 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	22.2% 4/18 • Number of events 5 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	3.4% 1/29 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	50.0% 9/18 • Number of events 18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/18 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	33.3% 1/3 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	16.7% 3/18 • Number of events 9 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	14.3% 1/7 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
Skin and subcutaneous tissue disorders Trichorrhexis	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/3 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/29 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/13 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	5.6% 1/18 • Number of events 1 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.	0.00% 0/7 • From start of study drug administration up to approximately 21 months The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Publication restrictions are in place

Restriction type: OTHER