Trial Outcomes & Findings for To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) (NCT NCT01768572)

Last Updated: 2017-06-26

Results Overview

Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. All adverse events that occurred from the first dose of the study drug administration up to 60 days after the end of treatment visit were considered as TEAEs. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. A summary of SAEs, all other non-serious AEs, regardless of causality, are reported in AE section.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

202 participants

Primary outcome timeframe

Up to 211 days

Results posted on

2017-06-26

Participant Flow

The study was conducted at 78 centers in 19 countries. A total of 389 participants were screened between 25 March 2013 and 02 April 2014, 187 of whom were screen failures. Screen failures were mainly due to failure to meet inclusion and exclusion criteria.

Randomization of participants were stratified by region and screening value of absolute neutrophil count. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in 1:1:2 (sarilumab 150 mg q2w: sarilumab 200 mg q2w: tocilizumab q4w). 202 participants were randomized.

Participant milestones

Participant milestones
Measure	Sarilumab 150 mg q2w Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD) for 24 weeks.	Sarilumab 200 mg q2w Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.	Tocilizumab q4w Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.
Overall Study STARTED	49	51	102
Overall Study COMPLETED	40	39	96
Overall Study NOT COMPLETED	9	12	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Sarilumab 150 mg q2w Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD) for 24 weeks.	Sarilumab 200 mg q2w Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.	Tocilizumab q4w Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.
Overall Study Adverse Event	7	8	4
Overall Study Lack of Efficacy	1	3	1
Overall Study Other, Not due to an adverse event	1	1	1

Baseline Characteristics

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sarilumab 150 mg q2w n=49 Participants Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.	Sarilumab 200 mg q2w n=51 Participants Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.	Tocilizumab q4w n=102 Participants Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.	Total n=202 Participants Total of all reporting groups
Age, Continuous	54.8 years STANDARD_DEVIATION 12.1 • n=5 Participants	51.7 years STANDARD_DEVIATION 13.1 • n=7 Participants	50.4 years STANDARD_DEVIATION 13.0 • n=5 Participants	51.8 years STANDARD_DEVIATION 12.8 • n=4 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	39 Participants n=7 Participants	82 Participants n=5 Participants	162 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants	40 Participants n=4 Participants
Duration of rheumatoid arthritis (RA) since diagnosis	13.59 years STANDARD_DEVIATION 8.24 • n=5 Participants	10.45 years STANDARD_DEVIATION 7.57 • n=7 Participants	10.84 years STANDARD_DEVIATION 8.91 • n=5 Participants	11.41 years STANDARD_DEVIATION 8.48 • n=4 Participants
RA functional class I	10 participants n=5 Participants	4 participants n=7 Participants	16 participants n=5 Participants	30 participants n=4 Participants
RA functional class II	25 participants n=5 Participants	33 participants n=7 Participants	62 participants n=5 Participants	120 participants n=4 Participants
RA functional class III	14 participants n=5 Participants	14 participants n=7 Participants	24 participants n=5 Participants	52 participants n=4 Participants
RA functional class IV	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Health Assessment Questionnaire Disability Index (HAQ-DI)	1.63 units on a scale STANDARD_DEVIATION 0.66 • n=5 Participants	1.71 units on a scale STANDARD_DEVIATION 0.60 • n=7 Participants	1.78 units on a scale STANDARD_DEVIATION 0.63 • n=5 Participants	1.72 units on a scale STANDARD_DEVIATION 0.63 • n=4 Participants
Disease Activity Score for 28 Joints- C-reactive protein (DAS28-CRP)	5.85 score on scale STANDARD_DEVIATION 0.92 • n=5 Participants	5.88 score on scale STANDARD_DEVIATION 0.97 • n=7 Participants	5.91 score on scale STANDARD_DEVIATION 1.01 • n=5 Participants	5.89 score on scale STANDARD_DEVIATION 0.97 • n=4 Participants

PRIMARY outcome

Timeframe: Up to 211 days

Population: The safety population consisted of all randomized participants who received at least 1 dose or a partial dose of study drug analyzed according to the treatment actually received.

Outcome measures

Outcome measures
Measure	Sarilumab 150 mg q2w n=49 Participants Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.	Sarilumab 200 mg q2w n=51 Participants Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.	Tocilizumab q4w n=102 Participants Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE	33 participants	36 participants	68 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any treatment-emergent SAE	1 participants	3 participants	7 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE leading to death	0 participants	0 participants	1 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE leading to discontinuation	6 participants	8 participants	4 participants

Adverse Events

Sarilumab 150 mg q2w

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Sarilumab 200 mg q2w

Serious events: 3 serious events

Other events: 36 other events

Deaths: 0 deaths

Tocilizumab q4w

Serious events: 7 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sarilumab 150 mg q2w n=49 participants at risk Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.	Sarilumab 200 mg q2w n=51 participants at risk Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.	Tocilizumab q4w n=102 participants at risk Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.
Infections and infestations Erysipelas	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.98% 1/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
Infections and infestations Septic shock	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.98% 1/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
Infections and infestations Urinary tract infection	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	2.0% 1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
Blood and lymphatic system disorders Neutropenia	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.98% 1/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
Nervous system disorders Tremor	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.98% 1/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
Cardiac disorders Atrial fibrillation	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	2.0% 1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
Vascular disorders Deep vein thrombosis	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.98% 1/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.98% 1/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
Renal and urinary disorders Renal failure acute	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.98% 1/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
Investigations Transaminases increased	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	2.0% 1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.	0.00% 0/102 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.

Other adverse events

Additional Information

Trial Transparency Team

Sanofi

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER