Trial Outcomes & Findings for Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis (NCT NCT02473965)

Last Updated: 2020-03-30

Results Overview

The average daily CS dose was derived for each subject at each scheduled visit based on the prescribed dose and the time interval taking into account any prescribed dose changes between routinely scheduled visits. Subjects who discontinued the study early with adverse outcomes related to MG were considered as not achieving a 50% or greater reduction. The missing dose reduction at Week 39 was imputed using the worst observation carried forward (WOCF) method. For subjects who did not have CS dose prescribed at Week 39 due to other reasons, the last observation carried forward (LOCF) method was used to impute the prescribed CS dose at Week 39. Baseline was defined as the last non-missing measurement taken prior to first dose of study medication. The percent of subjects achieving ≥50% reduction in CS dose from baseline to Week 39 is presented for each treatment group overall and for the baseline daily prednisone equivalent dose level stratification categories.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Baseline/Week 0 (Visit 1) and Week 39 (Visit 14).

Results posted on

2020-03-30

Participant Flow

Sixty subjects with a confirmed diagnosis of generalized myasthenia gravis (MG) historically meeting the clinical criteria for MG diagnosis Class II, III, IV or V of the Myasthenia Gravis Foundation of America were randomized. The study was conducted in 8 countries from November 2015 to February 2019.

Subjects had symptoms at screening controlled by corticosteroids (CS), had been dependent on systemic CS for at least the preceding 3 months and had received a stable dose of CS for at least 1 month immediately prior to the screening visit.

Participant milestones

Participant milestones
Measure	IGIV-C Investigational Product (IP) Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) were given a loading dose of 2 grams per kilogram (g/kg) by intravenous (IV) infusion at Baseline/Week 0 (Visit 1) and 2 maintenance doses of 1 g/kg at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses (1 g/kg) every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of IGIV-C was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.	Placebo IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive placebo were given 3 doses of placebo matching IGIV-C by IV infusion at Baseline/Week 0 (Visit 1) and at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses of placebo matching IGIV-C every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of placebo was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.
Overall Study STARTED	30	30
Overall Study COMPLETED	18	20
Overall Study NOT COMPLETED	12	10

Reasons for withdrawal

Reasons for withdrawal
Measure	IGIV-C Investigational Product (IP) Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) were given a loading dose of 2 grams per kilogram (g/kg) by intravenous (IV) infusion at Baseline/Week 0 (Visit 1) and 2 maintenance doses of 1 g/kg at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses (1 g/kg) every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of IGIV-C was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.	Placebo IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive placebo were given 3 doses of placebo matching IGIV-C by IV infusion at Baseline/Week 0 (Visit 1) and at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses of placebo matching IGIV-C every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of placebo was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.
Overall Study Adverse Event	6	4
Overall Study MG worsening	4	1
Overall Study Withdrawal by Subject	2	3
Overall Study Physician Decision	0	2

Baseline Characteristics

Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IGIV-C n=30 Participants IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive IGIV-C were given a loading dose of 2 g/kg by IV infusion at Baseline/Week 0 (Visit 1) and 2 maintenance doses of 1 g/kg at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses (1 g/kg) every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of IGIV-C was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.	Placebo n=30 Participants IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive placebo were given 3 doses of placebo matching IGIV-C by IV infusion at Baseline/Week 0 (Visit 1) and at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses of placebo matching IGIV-C every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of placebo was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.	Total Title n=60 Participants
Age, Continuous	47.6 years STANDARD_DEVIATION 16.99 • n=5 Participants	48.5 years STANDARD_DEVIATION 14.51 • n=7 Participants	48.1 years STANDARD_DEVIATION 15.67 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Daily Prednisone Equivalent Dose Level Stratification Categories 15 mg to 40 mg/day	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Baseline Daily Prednisone Equivalent Dose Level Stratification Categories 41 to 60 mg/day	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Baseline QMG Total Score	12.1 units on a scale STANDARD_DEVIATION 6.98 • n=5 Participants	11.2 units on a scale STANDARD_DEVIATION 6.48 • n=7 Participants	11.6 units on a scale STANDARD_DEVIATION 6.69 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline/Week 0 (Visit 1) and Week 39 (Visit 14).

Population: The mITT population included all randomized subjects who received at least 1 dose of study medication. Subjects were classified according to randomized treatment.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive placebo were given 3 doses of placebo matching IGIV-C by IV infusion at Baseline/Week 0 (Visit 1) and at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses of placebo matching IGIV-C every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of placebo was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.	IGIV-C n=30 Participants IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive IGIV-C were given a loading dose of 2 g/kg by IV infusion at Baseline/Week 0 (Visit 1) and 2 maintenance doses of 1 g/kg at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses (1 g/kg) every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of IGIV-C was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.
Percent of Subjects Achieving a 50% or Greater Reduction in CS Dose (Prednisone or Equivalent) From Baseline to Week 39 All subjects	63.3 percentage of subjects	60.0 percentage of subjects
Percent of Subjects Achieving a 50% or Greater Reduction in CS Dose (Prednisone or Equivalent) From Baseline to Week 39 15 mg to 40 mg/day	60.7 percentage of subjects	58.6 percentage of subjects
Percent of Subjects Achieving a 50% or Greater Reduction in CS Dose (Prednisone or Equivalent) From Baseline to Week 39 41 mg to 60 mg/day	100.0 percentage of subjects	100.0 percentage of subjects

SECONDARY outcome

Timeframe: Baseline/Week 0 (Visit 1) and Week 39 (Visit 14).

Population: The mITT population included all randomized subjects who received at least 1 dose of study medication. Subjects were classified according to randomized treatment.

The average daily CS dose was derived for each subject at each scheduled visit based on the prescribed dose and the time interval taking into account any prescribed dose changes between routinely scheduled visits. For subjects who discontinued the study early with adverse outcomes related to MG, the missing dose reduction at Week 39 was imputed using the WOCF method. For subjects who had missing CS dose reduction at Week 39 due to other reasons, the missing CS dose was imputed using the LOCF method. Baseline was defined as the last non-missing measurement taken prior to first dose of study medication. The least squares (LS) mean percent change from baseline in daily CS dose to Week 39 is presented for each treatment group.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive placebo were given 3 doses of placebo matching IGIV-C by IV infusion at Baseline/Week 0 (Visit 1) and at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses of placebo matching IGIV-C every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of placebo was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.	IGIV-C n=30 Participants IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive IGIV-C were given a loading dose of 2 g/kg by IV infusion at Baseline/Week 0 (Visit 1) and 2 maintenance doses of 1 g/kg at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses (1 g/kg) every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of IGIV-C was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.
Mean Percent Change in Daily CS Dose (Prednisone or Equivalent) From Baseline to Week 39	-54.15 percent change Standard Error 8.835	-52.57 percent change Standard Error 8.835

SECONDARY outcome

Timeframe: From Baseline/Week 0 (Visit 1) to Week 39 (Visit 14).

Population: The mITT population included all randomized subjects who received at least 1 dose of study medication. Subjects were classified according to randomized treatment.

The time to the first episode of MG worsening was defined as the time between baseline and the first instance of QMG total score increase by ≥4 points relative to Baseline/Week 0. The QMG total score is the sum of all 13 items and ranges from 0 to 39. Higher values represent greater severity of illness. If one or more items were missing at a given assessment, the total score was set to missing. The median time to MG worsening was calculated based on Kaplan-Meier methodology. Baseline was defined as the last non-missing measurement taken prior to the first dose of study medication.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive placebo were given 3 doses of placebo matching IGIV-C by IV infusion at Baseline/Week 0 (Visit 1) and at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses of placebo matching IGIV-C every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of placebo was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.	IGIV-C n=30 Participants IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive IGIV-C were given a loading dose of 2 g/kg by IV infusion at Baseline/Week 0 (Visit 1) and 2 maintenance doses of 1 g/kg at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses (1 g/kg) every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of IGIV-C was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.
Median Time to First Episode of MG Worsening	NA weeks Interval 30.1 to The median and 75th percentile were non-estimable as \>50% of subjects did not have an episode of MG worsening.	NA weeks Interval 33.1 to The median and 75th percentile were non-estimable as \>50% of subjects did not have an episode of MG worsening.

Adverse Events

IGIV-C

Serious events: 4 serious events

Other events: 21 other events

Deaths: 1 deaths

Placebo

Serious events: 6 serious events

Other events: 24 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	IGIV-C n=30 participants at risk IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive IGIV-C were given a loading dose of 2 g/kg by IV infusion at Baseline/Week 0 (Visit 1) and 2 maintenance doses of 1 g/kg at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses (1 g/kg) every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of IGIV-C was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.	Placebo n=30 participants at risk IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive placebo were given 3 doses of placebo matching IGIV-C by IV infusion at Baseline/Week 0 (Visit 1) and at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase. CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses of placebo matching IGIV-C every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of placebo was given. The last CS dose reduction was at Week 36 (Visit 13). Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments.
Nervous system disorders Myasthenia gravis	13.3% 4/30 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.	3.3% 1/30 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.
Nervous system disorders Myasthenia gravis crisis	3.3% 1/30 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.	6.7% 2/30 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/30 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.	3.3% 1/30 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.
Infections and infestations Pneumonia	0.00% 0/30 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.	3.3% 1/30 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.
Infections and infestations Sepsis	0.00% 0/30 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.	3.3% 1/30 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.
Infections and infestations Subcutaneous abscess	0.00% 0/30 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.	3.3% 1/30 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.
Infections and infestations Pneumonia staphylococcal	0.00% 0/30 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.	3.3% 1/30 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/30 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.	3.3% 1/30 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.
Cardiac disorders Cardiac arrest	0.00% 0/30 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.	3.3% 1/30 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/30 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.	3.3% 1/30 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Baseline/Week 0 to Week 39 (approximately 9 months). TEAEs are presented for the Safety population which consisted of all randomized subjects who received any amount of study medication. Subjects were classified according to the treatment received.

Other adverse events

Additional Information

Rhonda Griffin

Grifols Therapeutics LLC

Phone: 919-316-6693

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER