Trial Outcomes & Findings for Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) (NCT NCT02598661)

NCT ID: NCT02598661

Last Updated: 2026-01-05

Results Overview

Percentage of participants without any RBC transfusion during any consecutive 8 weeks (56 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2. The 95% confidence interval (CI) was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2/PHASE3

Target enrollment

289 participants

Primary outcome timeframe

Up to 5 years in Phase 2

Results posted on

2026-01-05

Participant Flow

Participants were enrolled in Phase 2 at 48 study sites and in the Phase 3 Study at 77 study sites. Data is reported for the Phase 2, Phase 3 and QTc substudy up to the primary completion date (PCD) of 13 October 2023. Enrolment in Extension phase started after October 2023 and analyses for the participants in extension phase is still ongoing, hence data for extension phase will be reported at study completion date in 2026.

57 participants with MDS received Imetelstat Sodium in Phase 2, followed by Phase 3 where 178 participants were randomized to receive either Imetelstat Sodium or Imetelstat sodium-matching placebo. 54 participants enrolled in QTc Substudy to receive either Imetelstat Sodium or Imetelstat sodium-matching placebo.

Participant milestones

Participant milestones
Measure
Phase 2: Imetelstat Sodium
Imetelstat sodium administered intravenously (IV), at a starting dose of 7.5 milligrams per kilogram (mg/kg), every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.
Overall Study
STARTED
57
118
60
35
19
Overall Study
Crossover to Imetelstat
0
0
0
0
14
Overall Study
Target Population
38
0
0
0
0
Overall Study
COMPLETED
15
57
29
33
17
Overall Study
NOT COMPLETED
42
61
31
2
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Phase 2: Imetelstat Sodium
Imetelstat sodium administered intravenously (IV), at a starting dose of 7.5 milligrams per kilogram (mg/kg), every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.
Overall Study
Death
27
34
14
1
0
Overall Study
Lost to Follow-up
2
3
2
0
0
Overall Study
Withdrawal by Subject
13
24
14
1
1
Overall Study
Adverse Event
0
0
1
0
0
Overall Study
Randomized, Never Treated
0
0
0
0
1

Baseline Characteristics

Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Phase 2: Imetelstat Sodium
n=57 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Imetelstat Sodium
n=118 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
n=60 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Imetelstat Sodium
n=35 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Placebo
n=18 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.
Total
n=288 Participants
Total of all reporting groups
Age, Continuous
70.1 years
n=9667 Participants
70.4 years
n=6597 Participants
71.7 years
n=16264 Participants
69.7 years
n=31 Participants
67.8 years
n=21 Participants
69.9 years
n=3 Participants
Sex: Female, Male
Female
25 Participants
n=9667 Participants
47 Participants
n=6597 Participants
20 Participants
n=16264 Participants
8 Participants
n=31 Participants
2 Participants
n=21 Participants
102 Participants
n=3 Participants
Sex: Female, Male
Male
32 Participants
n=9667 Participants
71 Participants
n=6597 Participants
40 Participants
n=16264 Participants
27 Participants
n=31 Participants
16 Participants
n=21 Participants
186 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=9667 Participants
6 Participants
n=6597 Participants
5 Participants
n=16264 Participants
0 Participants
n=31 Participants
0 Participants
n=21 Participants
12 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
48 Participants
n=9667 Participants
100 Participants
n=6597 Participants
48 Participants
n=16264 Participants
29 Participants
n=31 Participants
15 Participants
n=21 Participants
240 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
8 Participants
n=9667 Participants
12 Participants
n=6597 Participants
7 Participants
n=16264 Participants
6 Participants
n=31 Participants
3 Participants
n=21 Participants
36 Participants
n=3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9667 Participants
0 Participants
n=6597 Participants
0 Participants
n=16264 Participants
0 Participants
n=31 Participants
0 Participants
n=21 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
Asian
2 Participants
n=9667 Participants
8 Participants
n=6597 Participants
2 Participants
n=16264 Participants
3 Participants
n=31 Participants
0 Participants
n=21 Participants
15 Participants
n=3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9667 Participants
0 Participants
n=6597 Participants
0 Participants
n=16264 Participants
0 Participants
n=31 Participants
0 Participants
n=21 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=9667 Participants
1 Participants
n=6597 Participants
2 Participants
n=16264 Participants
1 Participants
n=31 Participants
1 Participants
n=21 Participants
6 Participants
n=3 Participants
Race (NIH/OMB)
White
46 Participants
n=9667 Participants
95 Participants
n=6597 Participants
48 Participants
n=16264 Participants
29 Participants
n=31 Participants
15 Participants
n=21 Participants
233 Participants
n=3 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=9667 Participants
0 Participants
n=6597 Participants
0 Participants
n=16264 Participants
0 Participants
n=31 Participants
0 Participants
n=21 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants
n=9667 Participants
14 Participants
n=6597 Participants
8 Participants
n=16264 Participants
2 Participants
n=31 Participants
2 Participants
n=21 Participants
34 Participants
n=3 Participants

PRIMARY outcome

Timeframe: Up to 5 years in Phase 2

Population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug.

Percentage of participants without any RBC transfusion during any consecutive 8 weeks (56 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2. The 95% confidence interval (CI) was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=57 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2: Percentage of Participants Without Any Red Blood Cell (RBC) Transfusion During Any Consecutive 8-Weeks Period (All Participants)
36.8 percentage of participants
Interval 24.45 to 50.66

PRIMARY outcome

Timeframe: Up to 5 years in Phase 2

Population: Phase 2: Target Population included participants without prior hypomethylating agent (HMA) or lenalidomide use and non del(5q) in karyotype at baseline.

Percentage of participants without any RBC transfusion during any consecutive 8 weeks (56 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2. The 95% confidence interval (CI) was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=38 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 8-Weeks Period in Target Population
42.1 percentage of participants
Interval 26.31 to 59.18

PRIMARY outcome

Timeframe: Up to 3.7 years in Phase 3

Population: Phase 3: The ITT Analysis Set included all participants randomized into the Phase 3 study.

Percentage of participants without any RBC transfusion during any consecutive 8 weeks (56 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2. The 95% CI was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=118 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=60 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 8-Weeks Period
39.8 percentage of participants
Interval 30.93 to 49.25
15.0 percentage of participants
Interval 7.1 to 26.57

SECONDARY outcome

Timeframe: Adverse events: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3; Deaths: Up to 6.6 years in Phase 2 and up to 4 years in Phase 3

Population: Phase 2 and Phase 3: Safety Analysis Set included all participants who received at least one dose of study drug.

TEAEs were defined as those events that 1) occurred after the first dose of study drug, through the treatment phase, and for 30 days following the last dose of study drug or until subsequent anti-cancer therapy if earlier; 2) any event that was considered study drug-related regardless of the start date of the event; or 3) any event that was presented at baseline but worsened in severity or was subsequently considered drug-related by the investigator. Serious TEAEs are any TEAEs that result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important. Any clinically significant vital sign measurements, clinical laboratory values, and electrocardiogram (ECG) findings were reported as TEAEs. TEAEs included both serious and non-serious TEAEs.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=50 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=7 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=118 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
n=59 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Deaths
Participants with AEs
50 Participants
6 Participants
117 Participants
59 Participants
Phase 2 and Phase 3: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Deaths
Participants who died
24 Participants
3 Participants
35 Participants
15 Participants

SECONDARY outcome

Timeframe: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3

Population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.

Percentage of participants without any RBC transfusion during any consecutive 24 weeks (168 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2 and the day of randomization for participants enrolled in Phase 3. The 95% CI was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=57 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=118 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=60 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 24-Weeks Period
24.6 percentage of participants
Interval 14.13 to 37.76
28.0 percentage of participants
Interval 20.1 to 36.98
3.3 percentage of participants
Interval 0.41 to 11.53

SECONDARY outcome

Timeframe: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3

Population: Phase 2: All Treated 8-week TI Responder Analysis Set included participants in the All Treated Analysis Set who achieved 8-week RBC TI. Phase 3: ITT 8-week TI Responder Analysis Set included all participants in the ITT Analysis Set who achieved 8-week RBC TI.

Time to 8-week RBC TI was defined as the interval from Study Day 1 to the first day of the first 8-week RBC TI period.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=21 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=47 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=9 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Time to the 8-Weeks RBC Transfusion Independence (TI)
8.29 weeks
Interval 0.1 to 100.6
9.29 weeks
Interval 0.1 to 64.7
8.29 weeks
Interval 0.1 to 46.9

SECONDARY outcome

Timeframe: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3

Population: Phase 2: All Treated 24-week TI Responder Analysis Set included participants in the All Treated Analysis Set who achieved 24-week RBC TI. Phase 3: ITT 24-week TI Responder Analysis Set included all participants in the ITT Analysis Set who achieved 24-week RBC TI.

Time to 24-week RBC TI was defined as the interval from Study Day 1 to the first day of the first 24-weeks RBC TI period.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=14 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=33 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=2 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Time to the 24-Weeks RBC TI
8.79 weeks
Interval 3.3 to 100.6
8.43 weeks
Interval 2.1 to 37.6
3.79 weeks
Interval 0.3 to 7.3

SECONDARY outcome

Timeframe: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3

Population: Phase 2: All Treated 8-week TI Responder Analysis Set included participants in the All Treated Analysis Set who achieved 8-week RBC TI. Phase 3: ITT 8-week TI Responder Analysis Set included all participants in the ITT Analysis Set who achieved 8-week RBC TI.

Duration of RBC TI was defined as the first day of the longest RBC TI period to the date of the first RBC transfusion after the TI period started. The 95% CI was based on Kaplan-Meier product limit estimates.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=21 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=47 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=9 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Duration of RBC TI
69.6 weeks
Interval 17.0 to 92.43
51.6 weeks
Interval 26.86 to 80.43
13.3 weeks
Interval 8.0 to 24.86

SECONDARY outcome

Timeframe: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3

Population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.

As per IWG Response Criteria 2006: HI-E was defined as a hemoglobin (Hb) increase by greater than or equal to (≥)1.5 grams per deciliter (g/dL) relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusion units/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a Hb of less than or equal to (≤)9 g/dL pretreatment were counted in the RBC transfusion response evaluation. The 95% CI was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=57 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=118 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=60 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Percentage of Participants With Hematologic Improvement Including Erythroid Response (HI-E) as Per International Working Group (IWG) Response Criteria 2006
61.4 percentage of participants
Interval 47.57 to 74.0
63.6 percentage of participants
Interval 54.2 to 72.22
51.7 percentage of participants
Interval 38.39 to 64.77

SECONDARY outcome

Timeframe: Up to 5 years in Phase 2

Population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug.

As per the IWG Response Criteria 2006, CR was defined as Bone marrow: ≤5% myeloblasts with normal maturation of all cell lines; Peripheral blood (PB): Hb ≥11 g/dL; platelets ≥100 x 10\^9/dL; neutrophils ≥1.0 x 10\^9/liter; blasts: 0%. PR was defined as Bone marrow: ≤5% myeloblasts and decrease by ≥50% over pretreatment; cellularity and morphology not relevant. mCR was defined as Bone marrow: ≤5% myeloblasts and decreased by ≥50% over pre-treatment PB. Percentages were rounded off to the nearest single decimal place. All participants in Phase 2 were evaluated by the Investigator for CR/PR/mCR regardless of bone marrow blasts at baseline.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=57 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2: Percentage of Participants With Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) as Per International Working Group (IWG) Response Criteria 2006 as Assessed by the Investigator
Percentage of participants with CR
8.8 percentage of participants
Phase 2: Percentage of Participants With Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) as Per International Working Group (IWG) Response Criteria 2006 as Assessed by the Investigator
Percentage of participants with PR
0 percentage of participants
Phase 2: Percentage of Participants With Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) as Per International Working Group (IWG) Response Criteria 2006 as Assessed by the Investigator
Percentage of participants with mCR
12.3 percentage of participants

SECONDARY outcome

Timeframe: Up to 3.7 years in Phase 3

Population: Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study. Overall number of participants analyzed is the number of participants with \>5% baseline bone marrow aspirate blasts per central pathology reviewer's assessment.

As per the IWG Response Criteria 2006, CR was defined as Bone marrow: ≤5% myeloblasts with normal maturation of all cell lines; PB: Hb ≥11 g/dL; platelets ≥100 x 10\^9/dL; neutrophils ≥1.0 x 10\^9/liter; blasts: 0%. PR was defined as Bone marrow: ≤5% myeloblasts and decrease by ≥50% over pretreatment; cellularity and morphology not relevant. mCR was defined as Bone marrow: ≤5% myeloblasts and decreased by ≥50% over pre-treatment PB. CR, PR and mCR were assessed by IRC in Phase 3 and participants were required to fit at least one of the following criteria (participants with \>5% baseline blasts per central pathology reviewer assessment; participants with CR, PR, mCR, or cytogenetic response as assessed by the investigator) and have at least one post-baseline assessment.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=1 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=1 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Percentage of Participants With CR, PR, or mCR as Per IWG Response Criteria 2006 as Assessed by the Independent Review Committee (IRC)
Percentage of participants with CR
0 percentage of participants
0 percentage of participants
Phase 3: Percentage of Participants With CR, PR, or mCR as Per IWG Response Criteria 2006 as Assessed by the Independent Review Committee (IRC)
Percentage of participants with PR
0 percentage of participants
0 percentage of participants
Phase 3: Percentage of Participants With CR, PR, or mCR as Per IWG Response Criteria 2006 as Assessed by the Independent Review Committee (IRC)
Percentage of participants with mCR
0 percentage of participants
0 percentage of participants

SECONDARY outcome

Timeframe: Up to 6.6 years in Phase 2 and up to 4 years in Phase 3

Population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.

OS was defined as the interval from Study Day 1 to death from any cause. Survival time of living participants was censored on the last date a participant is known to be alive or lost to follow-up. The Kaplan-Meier method was used to estimate overall survival.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=57 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=118 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=60 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Overall Survival (OS)
55.3 months
Interval 39.16 to
Upper limit of 95% CI was not estimable due to low number of participants with events.
40.4 months
Interval 37.06 to
Upper limit of 95% CI was not estimable due to low number of participants with events.
NA months
Interval 32.16 to
Median and upper limit of 95% CI were not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 6.6 years in Phase 2 and up to 4 years in Phase 3

Population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.

Progression free survival was defined as the time interval from study Day 1 to the first date of disease progression or death from any cause, whichever occurs first. Disease progression as per IWG criteria was defined as: at least one of the following: at least 50 % decrement from maximum response levels in granulocytes or platelets; reduction in hemoglobin by ≥1.5 g/dL; transfusion dependence.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=57 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=118 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=60 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Progression Free Survival (PFS)
34.2 months
Interval 25.1 to 39.29
NA months
Interval 29.24 to
Median and upper limit of 95% CI were not estimable due to low number of participants with events.
NA months
Interval 16.72 to
Median and upper limit of 95% CI were not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 6.6 years in Phase 2 and up to 4 years in Phase 3

Population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.

Time to progression to AML was defined as the interval from Study Day 1 to the date of AML diagnosis. Participants who did not progress to AML and were still alive at the cutoff date for the analysis or who withdrew from the study (withdrawal of consent or lost to follow-up), data was censored at the date of the last disease evaluation.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=57 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=118 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=60 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Time to Progression to Acute Myeloid Leukemia (AML)
NA months
Interval 41.36 to
Median and upper limit of 95% CI were not estimable by Kaplan-Meir method due to low number of participants with events.
NA months
Median, lower limit and upper limit of 95% CI were not estimable by Kaplan-Meir method due to low number of participants with events.
NA months
Median, lower limit and upper limit of 95% CI were not estimable by Kaplan-Meir method due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3

Population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.

Amount of RBC transfusions for 8-week interval was defined as the total number of RBC transfusion units in a given 8-week interval during study. The best 8-week interval is a post-baseline 8-week interval where the participant had the fewest post-Study Day 1 RBC transfusion units. A valid 8-week period must start before the date of last dose of study drug + 30 days or end of treatment (EOT) visit whichever occurs first and ends before the first transfusion in post-treatment follow-up or the first day of subsequent anti-cancer therapy whichever occurs first.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=57 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=118 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=60 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Amount of RBC Transfusions in the Best 8-week Interval
3.0 number of RBC transfusions units
Standard Deviation 3.48
3.1 number of RBC transfusions units
Standard Deviation 3.62
3.4 number of RBC transfusions units
Standard Deviation 2.13

SECONDARY outcome

Timeframe: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3

Population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.

Relative percent change in RBC transfusions per 8-week = (amount of RBC transfusions per 8-week - prior RBC transfusion burden) / prior RBC transfusion burden multiplied by 100%. Prior RBC transfusion burden was defined as the maximum number of RBC units transfused over any consecutive 8 weeks prior to study entry.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=57 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=118 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=60 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Percent Change in RBC Transfusions Relative to Prior Transfusion Burden
-62.5 percent change
Standard Deviation 38.36
-57.75 percent change
Standard Deviation 50.220
-51.01 percent change
Standard Deviation 31.606

SECONDARY outcome

Timeframe: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3

Population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.

Percentage of participants who received any myeloid growth factors starting from Study Day 1 were reported. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=57 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=118 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=60 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Percentage of Participants Who Received Any Myeloid Growth Factors
33 percentage of participants
35.6 percentage of participants
5.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3

Population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study. Overall number of participants analyzed is the number of participants who had at least 1 dose of myeloid growth factors in Phase 2 and Phase 3.

Duration of myeloid growth factor administered starting from Study Day 1 was reported.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=19 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=42 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
n=3 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Duration of Myeloid Growth Factors Administration
1.43 weeks
Interval 0.1 to 118.0
0.71 weeks
Interval 0.1 to 12.9
3.14 weeks
Interval 0.1 to 10.0

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1 and pre-dose on Day 1 of every 3 cycles from Cycle 4 up to Cycle 66 in Phase 2 and Cycle 34 in Phase 3 (each cycle length= 28 days)

Population: PK Parameter Analysis Set included all densely, and sparsely sampled participants who had received at least 1 dose of imetelstat sodium and who had sufficient data to calculate PK parameters for plasma imetelstat sodium. Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

As pre-specified in the statistical analysis plan (SAP), participants in the imetelstat sodium arm group of Phase 2 and Phase 3 were pooled for pharmacokinetic (PK) data collection and analyses in this outcome measure. PK parameters were determined by population PK model.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=170 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Maximum Observed Plasma Concentration (Cmax)
89.5 micrograms per milliliter (mcg/mL)
Standard Deviation 27.3

SECONDARY outcome

Timeframe: Cycle 1 (Days 1 to 28) (Cycle duration= 28 days)

Population: PK Parameter Analysis Set included all densely, and sparsely sampled participants who had received at least 1 dose of imetelstat sodium and who had sufficient data to calculate PK parameters for plasma imetelstat sodium. Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

As pre-specified in the statistical analysis plan (SAP), participants in the imetelstat sodium arm group of Phase 2 and Phase 3 were pooled for PK data collection and analyses in this outcome measure. PK parameters were determined by population PK model.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=170 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Area Under the Drug Concentration-Plasma Time Curve From Time Zero to Time 28 Days (AUC0-28d)
559 hour*micrograms per milliliter(h*mcg/mL)
Standard Deviation 43.2

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1 and pre-dose on Day 1 of every 3 cycles from Cycle 4 up to Cycle 66 in Phase 2 and Cycle 34 in Phase 3 (each cycle length= 28 days)

Population: The Pharmacodynamic (PD) Analysis Set included all participants who had at least one quantifiable post-dose determination on biomarker, efficacy or safety parameters as defined in the related Pharmacodynamics analysis plan. Overall number of participants analysed signifies those participants who were evaluable for this outcome measure.

As pre-specified in the SAP, participants in the imetelstat sodium arm group of Phase 2 and Phase 3 were pooled for immunogenicity data collection and analyses in this outcome measure. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=166 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2 and Phase 3: Percentage of Participants With Anti-drug Antibodies (ADA) to Imetelstat Sodium
16.9 percentage of participants

SECONDARY outcome

Timeframe: Up to 3.7 years in Phase 3

Population: Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.

Outpatient medical encounters included various sites of care: a) emergency room (ER) visits, b) hospital outpatient visits, c) home care visit, d) visit to lab, e) visit to doctor's office, f) other visits. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=118 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=60 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Medical Resource Utilization Assessed Based on Percentage of Participants With Outpatient Medical Encounters
39.0 percentage of participants
38.3 percentage of participants

SECONDARY outcome

Timeframe: Up to 3.7 years in Phase 3

Population: Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study. Overall number of participants analyzed is the number of participants who were hospitalized.

Hospitalization included any medical encounter defined as hospice, hospital inpatient department, and intensive care unit (ICU). Hospitalizations without end dates were not counted in the calculation of length of stay. If any participant had multiple readmissions, duration was calculated as the sum of all hospital stays.

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=43 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=14 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Medical Resource Utilization Assessed Based on Duration of Hospitalization
8.0 days
Interval 1.0 to 47.0
16.5 days
Interval 1.0 to 75.0

SECONDARY outcome

Timeframe: Baseline, Cycle 1, Day 1: 0.5, 1, 2, 4, 6, and 8 hours post-dose (cycle length= 28 days)

Population: The QTc substudy analysis set included all participants who participated in QTc substudy and received at least one dose of study drug, with measurements at baseline as well as on-treatment with at least 1 post-dose time point with a ΔQTcF value. By-time Point Analysis Set included each post-baseline time point that had a non-missing change-from-baseline observation. Number analysed is the number of participants with data available for analysis at specified timepoints.

Baseline was defined as the mean of the measured ECG intervals collected at 3 time points (-1 hour, -0.5 hour, and 0 hour) prior to treatment administration on Cycle 1 Day 1 (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure
Phase 2: Imetelstat Sodium
n=29 Participants
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Placebo
n=16 Participants
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Change From Baseline in QT Interval by Fridericia's Correction Method (ΔQTcF)
Change at 8 hr post-dose
2.3 milliseconds (ms)
Standard Error 2.53
-3.4 milliseconds (ms)
Standard Error 3.36
QTc Substudy: Change From Baseline in QT Interval by Fridericia's Correction Method (ΔQTcF)
Change at 0.5 hr post-dose
4.2 milliseconds (ms)
Standard Error 1.54
1.9 milliseconds (ms)
Standard Error 2.09
QTc Substudy: Change From Baseline in QT Interval by Fridericia's Correction Method (ΔQTcF)
Change at 1 hr post-dose
5.4 milliseconds (ms)
Standard Error 1.47
0.4 milliseconds (ms)
Standard Error 2.00
QTc Substudy: Change From Baseline in QT Interval by Fridericia's Correction Method (ΔQTcF)
Change at 2 hr post-dose
5.5 milliseconds (ms)
Standard Error 1.56
3.7 milliseconds (ms)
Standard Error 2.12
QTc Substudy: Change From Baseline in QT Interval by Fridericia's Correction Method (ΔQTcF)
Change at 4 hr post-dose
1.8 milliseconds (ms)
Standard Error 2.43
1.1 milliseconds (ms)
Standard Error 3.28
QTc Substudy: Change From Baseline in QT Interval by Fridericia's Correction Method (ΔQTcF)
Change at 6 hr post-dose
1.7 milliseconds (ms)
Standard Error 2.37
-1.1 milliseconds (ms)
Standard Error 3.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to approximately 3 years in the extension phase

An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. AEs included clinically significant vital signs measurements, clinical laboratory values and electrocardiograms (ECGs) changes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to approximately 3 years in the extension phase

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to approximately 3 years in the extension phase

Progression free survival will be assessed as the time interval from the end of the Phase 3 study until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. As per IWG criteria disease progression is defined as: at least one of the following: at least 50 percent (%) decrement from maximum response levels in granulocytes or platelets; reduction in hemoglobin by greater than or equal to ≥1.5 g/dL; transfusion dependence.

Outcome measures

Outcome data not reported

Adverse Events

Phase 2: Imetelstat Sodium (No Dose Escalation)

Serious events: 26 serious events
Other events: 50 other events
Deaths: 24 deaths

Phase 2: Imetelstat Sodium (Escalated to 9.4 mg/kg)

Serious events: 1 serious events
Other events: 6 other events
Deaths: 3 deaths

Phase 3: Imetelstat Sodium

Serious events: 41 serious events
Other events: 117 other events
Deaths: 35 deaths

Phase 3: Placebo

Serious events: 13 serious events
Other events: 58 other events
Deaths: 15 deaths

QTc Substudy: Imetelstat Sodium

Serious events: 8 serious events
Other events: 33 other events
Deaths: 1 deaths

QTc Substudy: Crossover Imetelstat Sodium

Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths

QTc Substudy: Placebo

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Phase 2: Imetelstat Sodium (No Dose Escalation)
n=50 participants at risk
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2: Imetelstat Sodium (Escalated to 9.4 mg/kg)
n=7 participants at risk
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) with dose escalation to 9.4 mg/kg allowed before Protocol Amendment 2, until death, lost to follow up, withdrawal of consent, or study termination, whichever occurs first.
Phase 3: Imetelstat Sodium
n=118 participants at risk
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
n=59 participants at risk
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Imetelstat Sodium
n=35 participants at risk
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Crossover Imetelstat Sodium
n=14 participants at risk
After a minimum of 2 treatment cycles (28-day cycle) if a participant had no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant was crossed over from placebo to receive imetelstat sodium 7.5 mg/kg.
QTc Substudy: Placebo
n=18 participants at risk
Imetelstat sodium matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.
Infections and infestations
Pneumonia
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.5%
3/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Atypical pneumonia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Bronchitis
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
COVID-19 pneumonia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
2/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.1%
3/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Cellulitis
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Cellulitis staphylococcal
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Corynebacterium infection
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Dermo-hypodermitis
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Disseminated tuberculosis
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Escherichia bacteraemia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Escherichia urinary tract infection
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Urosepsis
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Sepsis
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
2/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Urinary tract infection
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
2/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Clostridium difficile infection
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Enterococcal sepsis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Erysipelas
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Escherichia sepsis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Gastroenteritis clostridial
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Infection
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Neutropenic sepsis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Pneumonia bacterial
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Pseudomembranous colitis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Abscess limb
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
3.4%
2/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Arthritis bacterial
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Gastroenteritis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Listeriosis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Diarrhoea
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Gastric haemorrhage
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Gastrointestinal pain
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Inguinal hernia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Intestinal haemorrhage
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Oesophageal varices haemorrhage
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Thrombosis mesenteric vessel
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Faecaloma
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Gastrointestinal disorder
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Diverticular perforation
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Small intestinal haemorrhage
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Femur fracture
6.0%
3/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
2/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Blood and lymphatic system disorders
Cytopenia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Brain contusion
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Extradural haematoma
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Hip fracture
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Spinal compression fracture
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Toxicity to various agents
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Humerus fracture
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Joint dislocation
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Blood and lymphatic system disorders
Thrombocytopenia
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Blood and lymphatic system disorders
Anaemia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.5%
3/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Blood and lymphatic system disorders
Febrile neutropenia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Blood and lymphatic system disorders
Neutropenia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Nervous system disorders
Cerebrovascular accident
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Nervous system disorders
Headache
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Nervous system disorders
Neurodegenerative disorder
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Nervous system disorders
Sciatica
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Nervous system disorders
Syncope
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
2/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Cardiac disorders
Cardiac failure
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.5%
3/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Cardiac disorders
Cardiac failure congestive
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Cardiac disorders
Atrial fibrillation
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Cardiac disorders
Angina pectoris
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Cardiac disorders
Myocardial infarction
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Cardiac disorders
Aortic valve incompetence
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Cardiac disorders
Atrial flutter
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Haematoma
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Hypertension
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Hypertensive emergency
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Peripheral ischaemia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Deep vein thrombosis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Hypertensive crisis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Aortic stenosis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Extremity necrosis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Back pain
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Osteoarthritis
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Joint effusion
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Hepatobiliary disorders
Biliary colic
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Hepatobiliary disorders
Cholecystitis
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Metabolism and nutrition disorders
Hyperglycaemia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Metabolism and nutrition disorders
Haemochromatosis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Reproductive system and breast disorders
Prostatitis
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Pyrexia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
2/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Asthenia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Influenza like illness
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Renal and urinary disorders
Haematuria
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Renal and urinary disorders
Kidney congestion
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Renal and urinary disorders
Nephrolithiasis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Product Issues
Device occlusion
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Skin and subcutaneous tissue disorders
Diabetic foot
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Blood and lymphatic system disorders
Hypochromic anaemia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Joint abscess
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Staphylococcal bacteraemia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Staphylococcal sepsis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Respiratory, thoracic and mediastinal disorders
Lung infiltration
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Nervous system disorders
Cerebral infarction
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.

Other adverse events

Other adverse events
Measure
Phase 2: Imetelstat Sodium (No Dose Escalation)
n=50 participants at risk
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2: Imetelstat Sodium (Escalated to 9.4 mg/kg)
n=7 participants at risk
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) with dose escalation to 9.4 mg/kg allowed before Protocol Amendment 2, until death, lost to follow up, withdrawal of consent, or study termination, whichever occurs first.
Phase 3: Imetelstat Sodium
n=118 participants at risk
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
n=59 participants at risk
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Imetelstat Sodium
n=35 participants at risk
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Crossover Imetelstat Sodium
n=14 participants at risk
After a minimum of 2 treatment cycles (28-day cycle) if a participant had no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant was crossed over from placebo to receive imetelstat sodium 7.5 mg/kg.
QTc Substudy: Placebo
n=18 participants at risk
Imetelstat sodium matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.
Blood and lymphatic system disorders
Neutropenia
72.0%
36/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
28.6%
2/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
75.4%
89/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.5%
5/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
74.3%
26/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
57.1%
8/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
11.1%
2/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Blood and lymphatic system disorders
Thrombocytopenia
66.0%
33/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
28.6%
2/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
75.4%
89/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
10.2%
6/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
71.4%
25/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
64.3%
9/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
16.7%
3/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Blood and lymphatic system disorders
Anaemia
24.0%
12/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
19.5%
23/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
11.9%
7/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.6%
3/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Blood and lymphatic system disorders
Leukopenia
22.0%
11/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
10.2%
12/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
5/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
21.4%
3/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Pyrexia
20.0%
10/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.5%
10/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
11.9%
7/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Oedema peripheral
14.0%
7/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
12.7%
15/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
13.6%
8/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.6%
3/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
2/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Fatigue
10.0%
5/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
28.6%
2/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.6%
9/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
6.8%
4/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
5/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
2/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Asthenia
8.0%
4/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
28.6%
2/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
17.8%
21/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
13.6%
8/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.7%
2/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Influenza like illness
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
28.6%
2/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.7%
2/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Non-cardiac chest pain
6.0%
3/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Urinary tract infection
20.0%
10/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.9%
7/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
3.4%
2/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Nasopharyngitis
12.0%
6/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Bronchitis
12.0%
6/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Cellulitis
6.0%
3/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Upper respiratory tract infection
6.0%
3/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
COVID-19
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
16.1%
19/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
6.8%
4/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
11.4%
4/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Chest pain
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
2/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.5%
5/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Back pain
20.0%
10/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
9.3%
11/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.5%
5/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.7%
2/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Muscle spasms
10.0%
5/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Muscular weakness
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.7%
2/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Constipation
16.0%
8/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.5%
10/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
11.9%
7/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Arthralgia
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.5%
10/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.1%
6/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.1%
3/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.5%
5/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Diarrhoea
14.0%
7/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
28.6%
2/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
11.9%
14/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
11.9%
7/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
17.1%
6/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
21.4%
3/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Nausea
14.0%
7/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.6%
9/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.1%
3/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.7%
2/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
21.4%
3/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Vomiting
12.0%
6/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Abdominal pain
10.0%
5/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
6.8%
8/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
3.4%
2/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Abdominal pain upper
6.0%
3/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
28.6%
2/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
2/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
6.8%
4/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Gastritis
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Investigations
Alanine aminotransferase increased
14.0%
7/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
42.9%
3/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
11.0%
13/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
6.8%
4/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
17.1%
6/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
28.6%
4/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Investigations
Aspartate aminotransferase increased
12.0%
6/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
28.6%
2/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
9.3%
11/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
6.8%
4/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.6%
3/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
21.4%
3/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Investigations
Blood creatinine increased
8.0%
4/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
2/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.1%
3/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.7%
2/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Nervous system disorders
Headache
22.0%
11/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
28.6%
2/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
12.7%
15/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.1%
3/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.6%
3/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Nervous system disorders
Dizziness
8.0%
4/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.9%
7/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
6.8%
4/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.7%
2/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Metabolism and nutrition disorders
Decreased appetite
8.0%
4/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.7%
2/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
28.6%
4/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Metabolism and nutrition disorders
Hypokalaemia
6.0%
3/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Metabolism and nutrition disorders
Hyponatraemia
6.0%
3/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Metabolism and nutrition disorders
Hyperferritinaemia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.1%
6/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
3.4%
2/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Metabolism and nutrition disorders
Hyperkalaemia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
6.8%
4/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Metabolism and nutrition disorders
Iron overload
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.1%
3/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Respiratory, thoracic and mediastinal disorders
Cough
12.0%
6/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
2/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.1%
3/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.6%
3/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
2/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
10.0%
5/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
9.3%
11/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
10.2%
6/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Respiratory, thoracic and mediastinal disorders
Epistaxis
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.6%
9/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Hypertension
10.0%
5/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Haematoma
6.0%
3/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.9%
7/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Hypotension
6.0%
3/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Renal and urinary disorders
Haematuria
10.0%
5/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Contusion
6.0%
3/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.85%
1/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.1%
3/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Fall
6.0%
3/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Hepatobiliary disorders
Hyperbilirubinaemia
10.0%
5/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
11.4%
4/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Hepatobiliary disorders
Hepatomegaly
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Cardiac disorders
Atrial fibrillation
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.1%
6/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Skin and subcutaneous tissue disorders
Pruritus
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.9%
7/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
1.7%
1/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.7%
2/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Dry mouth
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Gastrointestinal pain
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Gastrooesophageal reflux disease
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Metabolism and nutrition disorders
Hyperglycaemia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
8.6%
3/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
2/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Metabolism and nutrition disorders
Gout
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Gait disturbance
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Infusion site discomfort
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Pain
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Peripheral swelling
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Investigations
Gamma-glutamyltransferase increased
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
2/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Investigations
Blood creatine phosphokinase increased
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Investigations
Serum ferritin increased
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Investigations
Troponin T increased
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Limb discomfort
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Gastroenteritis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Pneumonia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Nervous system disorders
Burning sensation
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Nervous system disorders
Hypoaesthesia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Nervous system disorders
Taste disorder
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Skin and subcutaneous tissue disorders
Rash
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Skin and subcutaneous tissue disorders
Skin ulcer
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Skin and subcutaneous tissue disorders
Hyperhidrosis
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Skin and subcutaneous tissue disorders
Purpura
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Skin and subcutaneous tissue disorders
Rash maculo-papular
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Skin and subcutaneous tissue disorders
Urticaria
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Hepatobiliary disorders
Hypertransaminasaemia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Cardiac disorders
Palpitations
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Cardiac disorders
Sinus tachycardia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Eye disorders
Vision blurred
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Flushing
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Hot flush
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Peripheral artery stenosis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Renal and urinary disorders
Acute kidney injury
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Renal and urinary disorders
Pollakiuria
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Animal bite
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Skin abrasion
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Psychiatric disorders
Confusional state
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
7.1%
1/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Stomatitis
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Dyspepsia
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Abdominal discomfort
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
General disorders
Chills
4.0%
2/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Ear and labyrinth disorders
Presbyacusis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Ear and labyrinth disorders
Ear congestion
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Psychiatric disorders
Sleep disorder
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Skin and subcutaneous tissue disorders
Melanoderma
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
2.9%
1/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
11.1%
2/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Wound infection
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Tooth infection
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Eye infection
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Investigations
Weight decreased
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Investigations
Cardiac murmur
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Osteonecrosis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
5.6%
1/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Skin and subcutaneous tissue disorders
Dry skin
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Renal and urinary disorders
Dysuria
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Flank pain
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Muscle contracture
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Haematochezia
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Haemorrhoids
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Food poisoning
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Gastric antral vascular ectasia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Gastric polyps
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Gastrointestinal angiectasia
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Nervous system disorders
Somnolence
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Thrombosis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Vascular disorders
Vasculitis
0.00%
0/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
Musculoskeletal and connective tissue disorders
Neck Pain
2.0%
1/50 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
14.3%
1/7 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/118 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/59 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/35 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/14 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.
0.00%
0/18 • Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.

Additional Information

Study Director

Geron Corp.

Phone: 650-473-7700

Results disclosure agreements

  • Principal investigator is a sponsor employee Consistent with Good Publication Practices and ICMJE guidelines, the sponsor shall have right to publish such primary (multicenter) data and information without approval from investigator. Investigator has right to publish study site-specific data after primary data published. If an investigator wishes to publish information from study, a copy of manuscript must be provided to sponsor for review at least 60 days before submission for publication or presentation.
  • Publication restrictions are in place

Restriction type: OTHER