Trial Outcomes & Findings for Safety & Efficacy Study of ORGN001 (Formerly ALXN1101) in Pediatric Patients With MoCD Type A Currently Treated With rcPMP (NCT NCT02047461)
NCT ID: NCT02047461
Last Updated: 2023-10-17
Results Overview
Treatment Emergent Serious Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Baseline to Month 24 for all patients plus additional follow-up up to Month 90
Results posted on
2023-10-17
Participant Flow
Patients who were currently receiving rcPMP infusions were enrolled and transitioned to ORGN001.
Participant milestones
| Measure |
Patients Currently Receiving rcPMP Infusions at Baseline and Transitioned to ORGN001
Patients currently receiving rcPMP infusions at baseline are transitioned to ORGN001 (formerly ALXN1101), starting at their current rcPMP dose and escalating to a target cPMP dose of 0.9 mg/kg.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety & Efficacy Study of ORGN001 (Formerly ALXN1101) in Pediatric Patients With MoCD Type A Currently Treated With rcPMP
Baseline characteristics by cohort
| Measure |
Patients Currently Receiving rcPMP Infusions at Baseline and Transitioned to ORGN001
n=8 Participants
Patients currently receiving rcPMP infusions at baseline are transitioned to ORGN001 (formerly ALXN1101), starting at their current rcPMP dose and escalating to a target dose of cPMP 0.9 mg/kg per protocol
|
|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
45.2 Months
STANDARD_DEVIATION 22.96 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=99 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=99 Participants
|
|
Region of Enrollment
Tunisia
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 24 for all patients plus additional follow-up up to Month 90Population: Full Analysis Set
Treatment Emergent Serious Adverse Events
Outcome measures
| Measure |
Patient Currently Receiving rcPMP Infusions at Baseline
n=8 Participants
Patient currently receiving rcPMP infusions at Baseline and transitioned to ORGN001
|
|---|---|
|
Safety of ORGN001 (Formerly ALXN1101)
Gastrointestinal disorders
|
1 events
|
|
Safety of ORGN001 (Formerly ALXN1101)
General disorders and administration site conditions
|
5 events
|
|
Safety of ORGN001 (Formerly ALXN1101)
Infections and infestations
|
6 events
|
|
Safety of ORGN001 (Formerly ALXN1101)
Injury, poisoning and procedural complications
|
2 events
|
|
Safety of ORGN001 (Formerly ALXN1101)
Metabolism and nutrition disorders
|
2 events
|
|
Safety of ORGN001 (Formerly ALXN1101)
Musculoskeletal and connective tissue disorders
|
1 events
|
|
Safety of ORGN001 (Formerly ALXN1101)
Nervous system disorders
|
2 events
|
|
Safety of ORGN001 (Formerly ALXN1101)
Product issues
|
1 events
|
|
Safety of ORGN001 (Formerly ALXN1101)
Respiratory, thoracic and mediastinal disorders
|
2 events
|
|
Safety of ORGN001 (Formerly ALXN1101)
Skin and subcutaneous tissue disorders
|
1 events
|
|
Safety of ORGN001 (Formerly ALXN1101)
Surgical and medical procedures
|
1 events
|
|
Safety of ORGN001 (Formerly ALXN1101)
Vascular disorders
|
2 events
|
SECONDARY outcome
Timeframe: First 6 months at each dose level, where availablePopulation: Measurement is actual plasma concentration of ORGN001 at measured timepoints, starting at their current rcPMP dose. 6 patients started at a dose of 240 mcg/kg, 1 patient at 248 mcg/kg, and 1 patient at 280 mcg/kg. (EOI = End of Infusion). 1 patient is missing a pre-infusion dose measurement.
ORGN001 levels by dose at pre-infusion and end of infusion (EOI) at scheduled timepoints
Outcome measures
| Measure |
Patient Currently Receiving rcPMP Infusions at Baseline
n=8 Participants
Patient currently receiving rcPMP infusions at Baseline and transitioned to ORGN001
|
|---|---|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 150 EOI (960 mcg/kg)
|
2045.67 ng/mL
Standard Deviation 1009.84
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 1 Pre-infusion (240 mcg/kg)
|
3.95 ng/mL
Standard Deviation 9.68
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 1 Pre-infusion (248 mcg/kg)
|
0 ng/mL
Standard Deviation NA
There is only one patient with data and therefore there is no Standard Deviation.
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 1 EOI (240 mcg/kg)
|
669.00 ng/mL
Standard Deviation 236.06
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 1 EOI (248 mcg/kg)
|
36.00 ng/mL
Standard Deviation NA
There is only one patient with data and therefore there is no Standard Deviation.
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 1 EOI (280 mcg/kg)
|
770.00 ng/mL
Standard Deviation NA
There is only one patient with data and therefore there is no Standard Deviation.
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 7 EOI (240 mcg/kg)
|
699.50 ng/mL
Standard Deviation 246.72
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 7 EOI (248 mcg/kg)
|
694.00 ng/mL
Standard Deviation NA
There is only one patient with data and therefore there is no Standard Deviation.
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 60 EOI (480 mcg/kg)
|
880.84 ng/mL
Standard Deviation 558.56
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 90 EOI (240 mcg/kg)
|
1230.00 ng/mL
Standard Deviation NA
There is only one patient with data and therefore there is no Standard Deviation.
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 90 EOI (480 mcg/kg)
|
762.00 ng/mL
Standard Deviation NA
There is only one patient with data and therefore there is no Standard Deviation.
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 90 EOI (720 mcg/kg)
|
1888.33 ng/mL
Standard Deviation 271.10
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 120 EOI (480 mcg/kg)
|
2810.00 ng/mL
Standard Deviation NA
There is only one patient with data and therefore there is no Standard Deviation.
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 120 EOI (720 mcg/kg)
|
671.00 ng/mL
Standard Deviation NA
There is only one patient with data and therefore there is no Standard Deviation.
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 120 EOI (960 mcg/kg)
|
4213.33 ng/mL
Standard Deviation 4520.31
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 150 EOI (720 mcg/kg)
|
3810.00 ng/mL
Standard Deviation NA
There is only one patient with data and therefore there is no Standard Deviation.
|
|
Pharmacokinetics (Actual Plasma Concentration) of ORGN001 (Formerly ALXN1101)
Day 150 EOI (1200 mcg/kg)
|
3173.33 ng/mL
Standard Deviation 656.53
|
SECONDARY outcome
Timeframe: Baseline to Month 24 for all patients plus additional follow-up to Month 90Population: Not all patients had samples taken at each expected timepoint.
Analyses were performed on urine SSC, a biomarker of the MoCD pathway. Levels of SSC measured in urine were normalized to urine creatinine levels. The observed value, change, and percent change in urine and blood SSC levels from baseline were summarized by visit over time.
Outcome measures
| Measure |
Patient Currently Receiving rcPMP Infusions at Baseline
n=8 Participants
Patient currently receiving rcPMP infusions at Baseline and transitioned to ORGN001
|
|---|---|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Baseline
|
21.1 umol/mmol
Standard Deviation 12.89
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Day 4 Change from Baseline
|
-1.7 umol/mmol
Standard Deviation 12.70
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Day 7 Change from Baseline
|
-7.8 umol/mmol
Standard Deviation 9.70
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Day 14 Change from Baseline
|
-2.2 umol/mmol
Standard Deviation 14.51
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Day 28 Change of Baseline
|
2.8 umol/mmol
Standard Deviation 14.17
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Day 57 Change from Baseline
|
-3.0 umol/mmol
Standard Deviation 10.29
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Day 127 Change from Baseline
|
-12.2 umol/mmol
Standard Deviation 14.77
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Month 6 Change from Baseline
|
-13.6 umol/mmol
Standard Deviation 11.77
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Month 12 Change from Baseline
|
-8.6 umol/mmol
Standard Deviation 20.15
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Month 24 Change from Baseline
|
-14.3 umol/mmol
Standard Deviation 14.73
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Month 36 Change from Baseline
|
-13.2 umol/mmol
Standard Deviation 18.40
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Month 48 Change from Baseline
|
-6.7 umol/mmol
Standard Deviation 6.65
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Month 60 Change from Baseline
|
-17.9 umol/mmol
Standard Deviation 14.59
|
|
S-sulfocysteine (Umol/L) Normalized to Urine Creatinine (mmol/L) - Change From Baseline Over Time
Month 90 Change from Baseline
|
1.7 umol/mmol
Standard Deviation 10.25
|
SECONDARY outcome
Timeframe: Baseline to Month 24 for all patients plus additional follow-up until Month 30Population: All patients entering the study had complete examinations throughout the study to identify Normal vs Abnormal Neurologic Function on the parameters presented. Date shown here are from Baseline and final examination where all 8 patients have data.
Change from baseline on repeated Neurologic examinations such as muscle strength and tone, as well as sensory and reflex exam.
Outcome measures
| Measure |
Patient Currently Receiving rcPMP Infusions at Baseline
n=8 Participants
Patient currently receiving rcPMP infusions at Baseline and transitioned to ORGN001
|
|---|---|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Quality of Spontaneous Movement at Baseline · Normal
|
3 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Quality of Spontaneous Movement at Baseline · Abnormal
|
5 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Quality of Spontaneous Movement at Month 30 · Normal
|
4 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Quality of Spontaneous Movement at Month 30 · Abnormal
|
4 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Dystonic at Baseline · Normal
|
4 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Dystonic at Baseline · Abnormal
|
4 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Dystonic at Month 30 · Normal
|
4 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Dystonic at Month 30 · Abnormal
|
4 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Opistonic at Baseline · Normal
|
7 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Opistonic at Baseline · Abnormal
|
1 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Opistonic at Month 30 · Normal
|
6 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Opistonic at Month 30 · Abnormal
|
2 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Truncal Tone at Baseline · Normal
|
2 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Truncal Tone at Baseline · Abnormal
|
5 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Truncal Tone at Month 30 · Normal
|
2 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Truncal Tone at Month 30 · Abnormal
|
6 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Appendicular Tone at Baseline · Normal
|
2 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Appendicular Tone at Baseline · Abnormal
|
6 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Appendicular Tone at Month 30 · Normal
|
1 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Appendicular Tone at Month 30 · Abnormal
|
7 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Deep Tendon reflexes at Baseline · Normal
|
4 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Deep Tendon reflexes at Baseline · Abnormal
|
4 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Deep Tendon reflexes at Month 30 · Normal
|
3 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Deep Tendon reflexes at Month 30 · Abnormal
|
5 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Primitive reflexes at Baseline · Normal
|
5 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Primitive reflexes at Baseline · Abnormal
|
1 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Primitive reflexes at Month 30 · Normal
|
6 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Primitive reflexes at Month 30 · Abnormal
|
1 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Clonus presence at Baseline · Normal
|
7 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Clonus presence at Baseline · Abnormal
|
1 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Clonus presence at Month 30 · Normal
|
6 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Clonus presence at Month 30 · Abnormal
|
2 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Ambulation at Baseline · Normal
|
4 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Ambulation at Baseline · Abnormal
|
4 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Ambulation at Month 30 · Normal
|
4 Participants
|
|
Effect of ORGN001 (Formerly ALXN1101) on Neurologic Function Including Motor Examination
Ambulation at Month 30 · Abnormal
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 24 for all patients plus additional follow up until Month 72Population: Number of patients with Seizures in observation period
Change from baseline in Seizure frequency
Outcome measures
| Measure |
Patient Currently Receiving rcPMP Infusions at Baseline
n=8 Participants
Patient currently receiving rcPMP infusions at Baseline and transitioned to ORGN001
|
|---|---|
|
Long-term Safety of ORGN001 (Formerly ALXN1101)
Screening
|
3 Participants
|
|
Long-term Safety of ORGN001 (Formerly ALXN1101)
Baseline to Month 6
|
4 Participants
|
|
Long-term Safety of ORGN001 (Formerly ALXN1101)
Month 6 to Month 12
|
3 Participants
|
|
Long-term Safety of ORGN001 (Formerly ALXN1101)
Month 12 to Month 24
|
3 Participants
|
|
Long-term Safety of ORGN001 (Formerly ALXN1101)
Month 24 to Month 36
|
3 Participants
|
|
Long-term Safety of ORGN001 (Formerly ALXN1101)
Month 36 to Month 48
|
3 Participants
|
|
Long-term Safety of ORGN001 (Formerly ALXN1101)
Month 48 to Month 60
|
3 Participants
|
|
Long-term Safety of ORGN001 (Formerly ALXN1101)
Month 60 to Month 72
|
3 Participants
|
Adverse Events
Patients Currently Receiving rcPMP Infusions at Baseline and Transitioned to ORGN001
Serious events: 8 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients Currently Receiving rcPMP Infusions at Baseline and Transitioned to ORGN001
n=8 participants at risk
Patients currently receiving rcPMP infusions at baseline are transitioned to ORGN001 (formerly ALXN1101), starting at their current rcPMP dose and escalating to a target dose of 0.9 mg/kg.
|
|---|---|
|
General disorders
Complication associated with device
|
50.0%
4/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Pyrexia
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Catheter site infections
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Device related infection
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Pneumonia
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Lower respiratory tract infection
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Vascular device infection
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
Other adverse events
| Measure |
Patients Currently Receiving rcPMP Infusions at Baseline and Transitioned to ORGN001
n=8 participants at risk
Patients currently receiving rcPMP infusions at baseline are transitioned to ORGN001 (formerly ALXN1101), starting at their current rcPMP dose and escalating to a target dose of 0.9 mg/kg.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Blood and lymphatic system disorders
Splenomegaly
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Cardiac disorders
Tachycardia
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Ear and labyrinth disorders
Ear Pain
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Eye disorders
Chalazion
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Eye disorders
Eye irritation
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Eye disorders
Eye pruritus
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Eye disorders
Eye swelling
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Eye disorders
Strabismus
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Diarrhoea
|
37.5%
3/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Gastritis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Retching
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Teething
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Vomiting
|
87.5%
7/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Catheter site discharge
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Catheter site discoloration
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Catheter site extravasation
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Catheter site haemorrhage
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Catheter site irritation
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Catheter site oedema
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Gastrointestinal disorders
Catheter site pain
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Chills
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Complication associated with device
|
75.0%
6/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Gait disturbance
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Medical device site discomfort
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Medical device site reaction
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Pain
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Pyrexia
|
87.5%
7/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Swelling
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
General disorders
Swelling face
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Bacteraemia
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Blister infected
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Bronchitis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Bronchitis viral
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Bullous impetigo
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
COVID-19
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Catheter site abscess
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Catheter site infection
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Conjunctivitis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Device related infection
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Ear infection
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Ear infection viral
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Eye infection
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Gastroenteritis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Gastroenteritis viral
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Hordeolum
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Influenza
|
50.0%
4/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Lower respiratory tract infection
|
37.5%
3/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Oral candidiasis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Otitis media
|
37.5%
3/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Otitis media acute
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Paronychia
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Pharyngitis
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Pneumonia
|
50.0%
4/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Pneumonia influenzal
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Pustule
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Respiratory tract infection
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Respiratory tract infection viral
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Rhinitis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Rhinovirus infection
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Sepsis
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Urinary tract infection
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Urinary tract infection bacterial
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Varicella
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Vascular device infection
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Viral infection
|
62.5%
5/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Viral tonsillitis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Infections and infestations
Viral upper respiratory tract infection
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Injury, poisoning and procedural complications
Muscle injury
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Injury, poisoning and procedural complications
Scar
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Injury, poisoning and procedural complications
Tendon injury
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Injury, poisoning and procedural complications
Thermal burn
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Investigations
Blood iron decreased
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Investigations
C-reactive protein increased
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Investigations
Cardiac murmur
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Investigations
Culture urine positive
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Investigations
Heart rate increased
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Investigations
Procalcitonin increased
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Investigations
Vitamin D decreased
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Metabolism and nutrition disorders
Iron deficiency
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Musculoskeletal and connective tissue disorders
Growth retardation
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Musculoskeletal and connective tissue disorders
Kyphoscoliosis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Nervous system disorders
Cerebral atrophy
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Nervous system disorders
Dystonia
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Nervous system disorders
Epilepsy
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Nervous system disorders
Hypertonia
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Nervous system disorders
Muscle spasticity
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Nervous system disorders
Opisthotonos
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Nervous system disorders
Seizure
|
37.5%
3/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Nervous system disorders
Tonic convulsion
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Nervous system disorders
Tremor
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Product Issues
Device dislocation
|
37.5%
3/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Product Issues
Device leakage
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Product Issues
Device occlusion
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Psychiatric disorders
Agitation
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Psychiatric disorders
Irritability
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Psychiatric disorders
Sleep disorder
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Reproductive system and breast disorders
Acute respiratory failure
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
4/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Skin and subcutaneous tissue disorders
Purpura
|
12.5%
1/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.5%
3/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
2/8 • Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
All-cause Mortality is zero in this study because there were no deaths that occurred. All SAE data is included
|
Additional Information
Business Development and Operations
Origin Biosciences (affiliate of BridgeBio)
Phone: 650-391-9740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution/Investigator shall have the right to publish or present the results of Institution's and Investigator's activities including that Study Data which was obtained or derived at Institution. Institution/ Investigator agree to submit any proposed publication/presentation to Sponsor for review at least 60 days prior to submitting any such proposed publication. Within 30 days of its receipt, Sponsor shall advise if any changes are needed to protect confidentiality.
- Publication restrictions are in place
Restriction type: OTHER